Traditional Chinese medicine composition for treating acute pharyngitis as well as preparation method and application thereof

Abstract

The invention discloses a traditional Chinese medicine composition for treating acute pharyngitis as well as a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicines. The technical problems to be solved are that the traditional Chinese medicine composition for treating acute pharyngitis is not suitable for long-term administration, is not suitable for sensitive people and is easy to damage spleen and stomach. The invention provides a traditional Chinese medicine composition for treating acute pharyngitis. The traditional Chinese medicine composition is prepared from the following raw materials: honeysuckle flower, fructus forsythiae, radix isatidis, herba menthae, radix bupleuri, fructus arctii, schizonepeta spike, gypsum, radix scutellariae, fructus gardeniae, radix platycodonis, radix paeoniae rubra, rhizoma phragmitis, semen armeniacae amarae, herba lophatheri, fructus aurantii, radix saposhnikoviae, medicated leaven, stiff silkworm and liquorice root. The traditional Chinese medicine composition disclosed by the invention can inhibit inflammatory reaction by inhibiting phosphorylation levels of PI3K / AKT and RAS / MAPK signal pathways AKT and MAPK, so that acute pharyngitis is improved.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition for treating acute pharyngitis, its preparation method, and its application. Background Technology

[0002] Pharyngitis is a common and prevalent disease in humans. However, some patients may experience prolonged illness or recurrent attacks due to specific pathogens, drug resistance, or improper treatment. In the past, it was not taken seriously in medical prevention and treatment. In addition, there were no corresponding treatment methods and drugs, so the general anti-inflammatory treatment used in the past was still used in clinical practice, which could not achieve good results.

[0003] Currently, the main clinical treatment for acute pharyngitis involves systemic antibiotics such as penicillin, amoxicillin, and cephalosporins, or local treatments such as lozenges and sprays with analgesic and antibacterial effects. Some patients may choose not to use medication and wait for natural recovery. However, the overuse of various antibiotics during treatment can easily lead to severe damage to the patient's spleen and stomach. Furthermore, the widespread use of antibiotics may result in increased drug resistance, dysbiosis, and other side effects. Not using medication may lead to prolonged illness or worsening of the condition.

[0004] Traditional Chinese medicine (TCM) believes that pharyngitis originates in the throat, but its pathogenesis is closely related to the lungs, liver, stomach, and kidneys. Therefore, pharyngitis should not be treated hastily with anti-inflammatory Western medicines. According to TCM theory, the treatment approach for acute pharyngitis involves clearing the lungs and resolving phlegm, dispersing wind-heat, reducing swelling and soothing the throat, dispersing blood stasis and relieving pain, and purging heat and detoxifying. This approach involves differentiating syndromes and combining formulas to achieve both symptomatic and root-cause treatment.

[0005] Relevant patent documents retrieved: The document, published in China (CN104666963A) on June 3, 2015, discloses a pediatric anti-inflammatory oral liquid. This oral liquid is made from traditional Chinese medicines including Pu Di Lan, Jin Yin Hua, Lian Qiao, Ku Di Ding, Ban Lan Gen, Chai Hu, San Qi, Huang Qin, Bo He, Ge Gen, Xing Ren, Gan Cao, Dan Zhu Ye, Jing Jie, Da Qing Ye, and Niu Bang Zi. It is used to treat boils, mumps, pharyngitis, and tonsillitis.

[0006] The publication country is China, publication number CN120815094A, publication date October 21, 2025. This document discloses the use of a naturally derived compound monomer composition in the preparation of an injectable drug for the prevention and / or treatment of pancreatitis. The drug composition comprises baicalin, paeoniflorin, geniposide, wogonin, baicalein, paeoniflorin lactone, tetrahydropalmatine, rhein, wogonin, aloe-emodin, saikosaponin A, emodin, benzoylpaeoniflorin, chlorogenic acid, costone lactone, or pharmaceutically acceptable salts thereof.

[0007] The document, published in China (CN101474373B) on March 16, 2011, discloses a traditional Chinese medicine for acute pharyngitis. The medicine includes perilla leaves, mint, dried plum, green plum, kudzu root, reed rhizome, platycodon root, licorice, borax, borneol, sucrose, and dextrin.

[0008] The prior art represented by the aforementioned documents has at least the following unresolved technical problems or defects: 1. Publication No. CN104666963A discloses that several traditional Chinese medicines, including honeysuckle, forsythia, isatis root, bupleurum, scutellaria, peppermint, apricot kernel, licorice, light bamboo leaf, burdock seed, and schizonepeta, have anti-inflammatory effects. However, it does not clarify the specific targets and pathways of action for acute pharyngitis, and the mechanism of action is not clear enough. Furthermore, the formulation does not consider the protection of the spleen and stomach, and may not be suitable for long-term use or for those with weak spleen and stomach.

[0009] 2. Publication number CN101474373A discloses a traditional Chinese medicine for acute pharyngitis, in which borax is included as an excipient. However, the human body absorbs boron quickly but excretes it slowly. Excessive intake can also have a strong toxic effect on the human body, which limits its use to special groups such as children and pregnant women.

[0010] 3. Existing traditional Chinese medicine preparations have not elucidated their core targets and pathways, resulting in a vague drug action mechanism, making it difficult to achieve precise treatment and hindering subsequent drug optimization and upgrading. Summary of the Invention

[0011] The purpose of this invention is to provide: A traditional Chinese medicine composition for treating acute pharyngitis, its preparation method and application, and related technologies, to solve technical problems such as the traditional Chinese medicine composition for treating acute pharyngitis being unsuitable for long-term use, unsuitable for sensitive populations, and easily damaging the spleen and stomach, or a combination thereof.

[0012] Terminology Explanation: Unless otherwise defined, all technical terms in this document have the same meanings as commonly understood by one of ordinary skill in the art to which the subject matter of the claims pertains. Unless otherwise stated, all patents, patent inventions, and publications cited in this document are incorporated herein by reference in their entirety. If multiple definitions exist for terms in this document, the definitions in this chapter shall prevail.

[0013] It should be understood that the above brief description and the following detailed description are exemplary and for illustrative purposes only, and do not limit the subject matter of the invention in any way. In this invention, the singular is used in conjunction with the plural unless otherwise specifically stated. It should also be noted that, unless otherwise stated, the use of “or” or “or” means “and / or”. Furthermore, the use of the term “comprising” and other forms such as “including,” “containing,” and “contains” are not limiting.

[0014] The definitions of standard terms can be found in the reference "Pharmacopoeia of the People's Republic of China (2020 Edition)".

[0015] Unless otherwise stated, conventional methods within the scope of the art, such as animal model construction and Western blotting experiments, shall be used.

[0016] Unless specifically defined herein, the use of all commercially available products herein employs standard techniques. For example, it may be carried out using the manufacturer's instructions for use with the kit, or in accordance with methods known in the art or the description of this invention. The techniques and methods described herein can generally be implemented according to conventional methods well known in the art, based on the descriptions in the various summary and more specific documents cited and discussed in this specification.

[0017] The term "honeysuckle" used in this article refers to: Its properties are sweet and cold. It is used to treat febrile diseases, dysentery caused by heat toxins, carbuncles, boils, scrofula, and hemorrhoids.

[0018] The term "Forsythia" as used in this article refers to the dried fruit of the Forsythia suspensa plant, belonging to the Oleaceae family. Its properties are bitter and slightly cold. It is used for carbuncles, scrofula, mastitis, erysipelas, wind-heat common cold, initial stages of febrile diseases, febrile diseases affecting the nutritive level, high fever with thirst, delirium with rashes, and painful urination due to heat.

[0019] The term "Isatis root" as used in this article refers to: Its properties are bitter and cold. It is used for febrile diseases with rashes, dark purple tongue, mumps, sore throat, erysipelas, epidemic parotitis, erysipelas, and carbuncles.

[0020] The term "peppermint" as used in this article refers to: Its properties are pungent and cool. It is used to treat exogenous wind-heat, headache, red eyes, sore throat, indigestion and bloating, mouth ulcers, toothache, sores and rashes.

[0021] The term "Bupleurum" as used in this article refers to: Properties: Bitter, slightly cold. Channels entered: Liver and Gallbladder. Functions and indications: Harmonizes the exterior and interior, soothes the liver, and raises Yang. Used for colds with fever, alternating chills and fever, chest and rib pain, irregular menstruation, uterine prolapse, and rectal prolapse.

[0022] The term "burdock seed" as used in this article refers to the dried, mature fruit of *Arctium lappa*, a plant belonging to the genus *Arctium* in the family Asteraceae. Its properties are pungent, bitter, and cold. It is used for wind-heat type common cold, cough with excessive phlegm, measles, rubella, sore throat, mumps, erysipelas, carbuncles, and boils.

[0023] The term "Nepeta cataria spike" used in this article refers to the dried flower spike of Nepeta cataria, a plant in the Lamiaceae family. Its properties are pungent and slightly warm. When charred, it has hemostatic effects and can be used for hematochezia, metrorrhagia, and postpartum hemorrhage.

[0024] The term "gypsum" as used in this article refers to: Gypsum of the gypsum group of sulfate minerals, mainly containing calcium sulfate dihydrate (CaSO4·2H2O). After mining, impurities and sediment are removed. It has the effects of clearing heat and purging fire, removing vexation and quenching thirst. It is used for exogenous febrile diseases, high fever with vexation and thirst, cough and asthma due to lung heat, excessive fire of the stomach, headache, and toothache.

[0025] The term "scutellaria baicalensis" as used in this article refers to: Nature and flavor: bitter, cold. It is used for damp-warmth, summer-warmth with chest distress and nausea, damp-heat stagnation, diarrhea, jaundice, cough due to lung heat, high fever with vexation and thirst, vomiting of blood due to blood heat, carbuncles and sores, and restless fetus.

[0026] The term "gardenia" as used in this article refers to: The dried ripe fruit of Gardenia jasminoides Ellis of the Rubiaceae family. It is used for vexation due to febrile diseases, damp-heat jaundice, stranguria with pain, vomiting of blood due to blood heat, red and swollen eyes, carbuncles and sores caused by fire-toxin; externally used for sprains and contusions.

[0027] The term "platycodon grandiflorum" as used in this article refers to: Nature and flavor: bitter, pungent, neutral. It is used for cough with profuse phlegm, chest distress, sore throat, hoarseness, lung abscess with expectoration of pus, and non-ulceration of abscesses in sores.

[0028] The term "red peony root" as used in this article refers to: The dried root of Paeonia lactiflora Pall. or Paeonia veitchii Lynch of the Ranunculaceae family. It is used for heat invading nutrient-blood, epidemic toxin causing maculae, vomiting of blood and nosebleed, red and swollen eyes, hypochondriac pain due to stagnation of liver qi, amenorrhea and dysmenorrhea, abdominal pain due to mass in the abdomen, injury from falls and bruises, carbuncles and sores.

[0029] The term "reed rhizome" as used in this article refers to: The fresh or dried rhizome of Phragmites communis Trin. of the Gramineae family. Nature and flavor: sweet, cold. It is used for febrile diseases with vexation and thirst, cough due to lung heat, lung abscess with expectoration of pus, vomiting due to stomach heat, and stranguria with pain.

[0030] The term "bitter apricot kernel" as used in this article refers to: Take clean bitter apricot kernels, stir-fry them according to the method of stir-frying with clear fire (General Rules 0213) until yellowish with slightly charred spots, take them out and let them cool, and crush them before use. It is mostly used for cough and asthma, fullness in the chest with profuse phlegm, constipation due to intestinal dryness, and reduces the toxicity of the raw product, with higher safety in medication.

[0031] The term "lophatherum gracile" as used in this article refers to: The dried stems and leaves of Lophatherum gracile Brongn. of the Gramineae family. Nature and flavor: sweet, light, cold. Meridian tropism: entering the heart, stomach, and small intestine meridians. Functional indications: clearing heat and purging fire, removing vexation and quenching thirst.

[0032] The term "immature bitter orange" as used in this article refers to: The dried unripe fruit of Citrus aurantium L. and its cultivated varieties or Citrus sinensis Osbeck of the Rutaceae family. It is used for food retention, fullness and distension in the epigastric and abdominal regions, constipation, tenesmus after diarrhea, phlegm stagnation and qi obstruction, chest impediment, knotted chest, and visceral ptosis.

[0033] The term "saposhnikovia divaricata" as used in this article refers to: The dried root of Saposhnikovia divaricata (Turcz.) Schischk. of the Umbelliferae family. Nature and flavor: pungent, sweet, slightly warm. It is used for colds, headache, rheumatic arthralgia, rubella itching, and tetanus.

[0034] The term "stir-fried Shenqu" used in this article refers to: taking clean Shenqu, stir-frying it according to the stir-frying method (General Rule 0213) until the surface turns brownish-yellow and a fragrant aroma is released, then removing it, letting it cool, and sifting out any debris. Functions and indications: aids digestion, strengthens the spleen and stomach.

[0035] The term "silkworm larva" as used in this article refers to the dried body of a 4th-5th instar silkworm larva (Bombyx mori) that has died from infection (or artificial inoculation) with Beauveria bassiana. It is used to treat infantile convulsions, sore throat, submandibular lymphadenitis, facial nerve paralysis, and pruritus.

[0036] The term "licorice" used in this article refers to: Its properties are sweet and neutral. Its functions and indications include: harmonizing the middle jiao (digestive system), relieving spasms, moistening the lungs, detoxifying, and harmonizing other herbs.

[0037] The term "geniposide" as used in this article refers to iridoid glycosides extracted from the dried, mature fruit of *Gardenia jasminoides*, a plant in the Rubiaceae family. It possesses various pharmacological effects, including anti-inflammatory, antioxidant, hepatoprotective, choleretic, hypoglycemic, and neuroprotective properties.

[0038] The term "paeoniflorin" as used in this article refers to a monoterpenoid glycoside compound extracted from the dried root (white or red peony root) of the Ranunculaceae plant Paeonia lactiflora. It possesses pharmacological effects including anti-inflammatory, analgesic, sedative, hepatoprotective, immunomodulatory, and anti-myocardial ischemia properties.

[0039] In a first aspect, the present invention provides: a traditional Chinese medicine composition for treating acute pharyngitis, comprising the following components by weight: honeysuckle 15-80 parts, forsythia 40-90 parts, isatis root 15-40 parts, peppermint 20-50 parts, bupleurum 25-40 parts, burdock fruit 10-45 parts, schizonepeta spike 25-40 parts, gypsum 10-60 parts, scutellaria baicalensis 35-60 parts, and gardenia 20-40 parts. The ingredients are: 15-40 parts Platycodon grandiflorus, 5-20 parts Paeonia lactiflora, 45-75 parts Phragmites communis, 10-70 parts Prunus armeniaca, 15-40 parts Lophatherum gracile, 15-40 parts Citrus aurantium, 15-50 parts Saposhnikovia divaricata, 15-35 parts Shenqu (medicated leaven), 20-40 parts Bombyx mori, and 10-25 parts Glycyrrhiza uralensis; the weight ratio of Lonicera japonica, Forsythia suspensa, Gardenia jasminoides to Paeonia lactiflora is 4-16:8-18:4-8:2-4.

[0040] As a preferred embodiment, the honeysuckle is selected from any value or range between 15 and 80 parts by weight; Preferably, the honeysuckle is selected from any value or range between 15 and 80 parts by weight, specifically from: 15 parts, 20 parts, 25 parts, 30 parts, 35 parts, 40 parts, 45 parts, 50 parts, 55 parts, 60 parts, 65 parts, 70 parts, 75 parts, 80 parts or a range between the two. More preferably, the honeysuckle is selected from any value or range between 15 and 80 parts by weight, specifically from: 20 parts, 25 parts, 55 parts, 60 parts, 70 parts, 75 parts, 80 parts or a range between the two. More preferably, the honeysuckle is selected from any value or range between 15 and 80 parts by weight, specifically from 20 parts, 60 parts, 80 parts or a range between the two. More preferably, the honeysuckle is in the form of 20 parts by weight.

[0041] As a preferred embodiment, the Forsythia suspensa is selected from any value or range between 40 and 90 parts by weight; Preferably, the Forsythia suspensa is selected from any value or range between 40 and 90 parts by weight, specifically from: 40 parts, 45 parts, 50 parts, 55 parts, 60 parts, 65 parts, 70 parts, 75 parts, 80 parts, 85 parts, 90 parts or a range between the two. More preferably, the Forsythia suspensa is selected from any value or range between 40 and 90 parts by weight, specifically from 40 parts, 65 parts, 90 parts or a range between the two. More preferably, the Forsythia suspensa is 40 parts by weight.

[0042] As a preferred embodiment, the Isatis root is selected from any value or range between 15 and 40 parts by weight; Preferably, the Isatis root is selected from any value or range between 15 and 40 parts by weight, specifically from: 15 parts, 20 parts, 25 parts, 30 parts, 35 parts, 40 parts or a range between the two. More preferably, the Isatis root is selected from any value or range between 15 and 40 parts by weight, specifically from 15 parts, 35 parts, 40 parts or a range between the two. More preferably, the amount of Isatis root is 40 parts by weight.

[0043] As a preferred embodiment, the peppermint is selected from any value or range between 20 and 50 parts by weight; Preferably, the peppermint is selected from any value or range between 20 and 50 parts by weight, specifically from: 20 parts, 25 parts, 30 parts, 35 parts, 40 parts, 45 parts, 50 parts or a range between the two. More preferably, the peppermint is selected from any value or range between 20 and 50 parts by weight, specifically from 20 parts, 35 parts, 50 parts or a range between the two. More preferably, the amount of mint is 50 parts by weight.

[0044] As a preferred embodiment, the Bupleurum chinense is selected from any value or range between 25 and 40 parts by weight; Preferably, the Bupleurum chinense is selected from any value or range between 25 and 40 parts by weight, specifically from: 25 parts, 26 parts, 27 parts, 28 parts, 29 parts, 30 parts, 32 parts, 35 parts, 38 parts, 40 parts or a range between the two. More preferably, the Bupleurum chinense is selected from any value or range between 25 and 40 parts by weight, specifically from: 25 parts, 26 parts, 29 parts, 30 parts, 32 parts, 35 parts, 38 parts, 40 parts or a range between the two. More preferably, the Bupleurum chinense is selected from any value or range between 25 and 40 parts by weight, specifically from 25 parts, 30 parts, 40 parts or a range between the two. More preferably, the Bupleurum chinense is 40 parts by weight.

[0045] As a preferred embodiment, the burdock seeds are selected from any value or range between 10 and 45 parts by weight; Preferably, the burdock seeds are selected from any value or range between 10 and 45 parts by weight, specifically from: 10 parts, 13 parts, 15 parts, 18 parts, 20 parts, 25 parts, 26 parts, 27 parts, 28 parts, 29 parts, 30 parts, 32 parts, 35 parts, 38 parts, 40 parts, 45 parts or a range between the two. More preferably, the burdock seeds are selected from any value or range between 10 and 45 parts by weight, specifically from: 10 parts, 13 parts, 15 parts, 30 parts, 32 parts, 35 parts, 38 parts, 40 parts, 45 parts or a range between the two. More preferably, the burdock seeds are selected from any value or range between 10 and 45 parts by weight, specifically from 10 parts, 35 parts, 45 parts or a range between the two. More preferably, the burdock seeds are 10 parts by weight.

[0046] As a preferred embodiment, the catnip spikes are selected from any value or range between 25 and 40 parts by weight; Preferably, the catnip spikes are selected from any value or range between 25 and 40 parts by weight, specifically from: 20 parts, 25 parts, 26 parts, 27 parts, 28 parts, 29 parts, 30 parts, 32 parts, 35 parts, 38 parts, 40 parts or a range between the two. More preferably, the catnip spikes are selected from any value or range between 25 and 40 parts by weight, specifically from: 25 parts, 29 parts, 30 parts, 32 parts, 35 parts, 38 parts, 40 parts or a range between the two. More preferably, the catnip spikes are selected from any value or range between 25 and 40 parts by weight, specifically from 25 parts, 35 parts, 40 parts or a range between the two. More preferably, the catnip spikes are 40 parts by weight.

[0047] As a preferred embodiment, the gypsum is selected from any value or range between 10 and 60 parts by weight; Preferably, the gypsum is selected from any value or range between 10 and 60 parts by weight, specifically from: 10 parts, 15 parts, 20 parts, 25 parts, 30 parts, 35 parts, 40 parts, 45 parts, 50 parts, 55 parts, 60 parts or a range between the two. More preferably, the gypsum is selected from any value or range between 10 and 60 parts by weight, specifically from: 10 parts, 15 parts, 30 parts, 35 parts, 40 parts, 45 parts, 55 parts, 60 parts or a range between the two. More preferably, the gypsum is selected from any value or range between 10 and 60 parts by weight, specifically from: 10 parts, 15 parts, 40 parts, 45 parts, 55 parts, 60 parts or a range between the two. More preferably, the gypsum is selected from any value or range between 10 and 60 parts by weight, specifically from 10 parts, 40 parts, 60 parts or a range between the two. More preferably, the gypsum is 10 parts by weight.

[0048] As a preferred embodiment, the Scutellaria baicalensis is selected from any value or range between 35 and 60 parts by weight; Preferably, the Scutellaria baicalensis is selected from any value or range between 35 and 60 parts by weight, specifically from: 35 parts, 40 parts, 45 parts, 50 parts, 55 parts, 60 parts or a range between the two. More preferably, the Scutellaria baicalensis is selected from any value or range between 35 and 60 parts by weight, specifically from 35 parts, 40 parts, 50 parts, 60 parts or a range between the two. More preferably, the Scutellaria baicalensis is selected from any value or range between 35 and 60 parts by weight, specifically from 35 parts, 50 parts, 60 parts or a range between the two. More preferably, the Scutellaria baicalensis is 60 parts by weight.

[0049] As a preferred embodiment, the gardenia is selected from any value or range between 20 and 40 parts by weight; Preferably, the gardenia is selected from any value or range between 20 and 40 parts by weight, specifically from: 20 parts, 23 parts, 25 parts, 28 parts, 30 parts, 32 parts, 35 parts, 38 parts, 40 parts or a range between the two. More preferably, the gardenia is selected from any value or range between 20 and 40 parts by weight, specifically from: 20 parts, 25 parts, 30 parts, 35 parts, 40 parts or a range between the two. More preferably, the gardenia is selected from any value or range between 20 and 40 parts by weight, specifically from 20 parts, 30 parts, 40 parts or a range between the two. More preferably, the gardenia is 40 parts by weight.

[0050] As a preferred embodiment, the platycodon root is selected from any value or range between 15 and 40 parts by weight; Preferably, the platycodon root is selected from any value or range between 15 and 40 parts by weight, specifically from: 15 parts, 18 parts, 20 parts, 23 parts, 25 parts, 28 parts, 30 parts, 32 parts, 35 parts, 38 parts, 40 parts or a range between the two. More preferably, the platycodon root is selected from any value or range between 15 and 40 parts by weight, specifically from: 15 parts, 18 parts, 20 parts, 23 parts, 35 parts, 38 parts, 40 parts or a range between the two. More preferably, the platycodon root is selected from any value or range between 15 and 40 parts by weight, specifically from 15 parts, 20 parts, 40 parts or a range between the two. More preferably, the platycodon root is 40 parts by weight.

[0051] As a preferred embodiment, the red peony root is selected from any value or range between 5 and 20 parts by weight; Preferably, the red peony root is selected from any value or range between 5 and 20 parts by weight, specifically from: 5 parts, 6 parts, 8 parts, 10 parts, 12 parts, 15 parts, 18 parts, 19 parts, 20 parts or a range between the two. More preferably, the red peony root is selected from any value or range between 5 and 20 parts by weight, specifically from: 8 parts, 10 parts, 12 parts, 15 parts, 18 parts, 19 parts, 20 parts or a range between the two. More preferably, the red peony root is selected from any value or range between 5 and 20 parts by weight, specifically from 10 parts, 15 parts, 20 parts or a range between the two. More preferably, the amount of red peony root is 20 parts by weight.

[0052] As a preferred embodiment, the reed rhizome is selected from any value or range between 45 and 75 parts by weight; Preferably, the reed rhizome is selected from any value or range between 45 and 75 parts by weight, specifically from: 45 parts, 48 ​​parts, 50 parts, 53 parts, 55 parts, 60 parts, 65 parts, 70 parts, 75 parts or a range between the two. More preferably, the reed rhizome is selected from any value or range between 45 and 75 parts by weight, specifically from: 45 parts, 48 ​​parts, 50 parts, 53 parts, 65 parts, 70 parts, 75 parts or a range between the two. More preferably, the reed rhizome is selected from any value or range between 45 and 75 parts by weight, specifically from 45 parts, 50 parts, 75 parts or a range between the two. More preferably, the reed rhizome is 75 parts by weight.

[0053] As a preferred embodiment, the bitter almonds are selected from any value or range between 10 and 70 parts by weight; Preferably, the bitter almonds are selected from any value or range between 10 and 70 parts by weight, specifically from: 10 parts, 15 parts, 20 parts, 25 parts, 30 parts, 35 parts, 40 parts, 45 parts, 50 parts, 55 parts, 60 parts, 65 parts, 70 parts or a range between the two. More preferably, the bitter almonds are selected from any value or range between 10 and 70 parts by weight, specifically from: 10 parts, 15 parts, 35 parts, 40 parts, 45 parts, 65 parts, 70 parts or a range between the two. More preferably, the bitter almonds are selected from any value or range between 10 and 70 parts by weight, specifically from 10 parts, 40 parts, 70 parts or a range between the two. More preferably, the bitter almonds are 10 parts by weight.

[0054] As a preferred embodiment, the Lophatherum gracile leaves are selected from any value or range between 15 and 40 parts by weight; Preferably, the light bamboo leaves are selected from any value or range between 15 and 40 parts by weight, specifically from: 15 parts, 18 parts, 20 parts, 25 parts, 28 parts, 30 parts, 35 parts, 40 parts or a range between the two. More preferably, the light bamboo leaves are selected from any value or range between 15 and 40 parts by weight, specifically from: 15 parts, 20 parts, 25 parts, 30 parts, 35 parts, 40 parts or a range between the two. More preferably, the light bamboo leaves are selected from any value or range between 15 and 40 parts by weight, specifically from: 15 parts, 25 parts, 30 parts, 35 parts, 40 parts or a range between the two. More preferably, the light bamboo leaves are selected from any value or range between 15 and 40 parts by weight, specifically from 15 parts, 30 parts, 40 parts or a range between the two. More preferably, the amount of light bamboo leaves is 40 parts by weight.

[0055] As a preferred embodiment, the bitter orange peel is selected from any value or range between 15 and 40 parts by weight; Preferably, the bitter orange peel is selected from any value or range between 15 and 40 parts by weight, specifically from: 15 parts, 20 parts, 25 parts, 30 parts, 35 parts, 40 parts or a range between the two. More preferably, the bitter orange peel is selected from any value or range between 15 and 40 parts by weight, specifically from: 15 parts, 25 parts, 30 parts, 35 parts, 40 parts or a range between the two. More preferably, the bitter orange peel is selected from any value or range between 15 and 40 parts by weight, specifically from 15 parts, 30 parts, 40 parts or a range between the two. More preferably, the amount of bitter orange peel is 40 parts by weight.

[0056] As a preferred embodiment, the windproof material is selected from any value or range between 15 and 50 parts by weight; Preferably, the windproof material is selected from any value or range between 15 and 50 parts by weight, specifically from: 15 parts, 20 parts, 25 parts, 30 parts, 35 parts, 40 parts, 45 parts, 50 parts or a range between the two. More preferably, the windproof material is selected from any value or range between 15 and 50 parts by weight, specifically from: 15 parts, 25 parts, 30 parts, 35 parts, 40 parts, 45 parts, 50 parts or a range between the two. More preferably, the windproof material is selected from any value or range between 15 and 50 parts by weight, specifically from 15 parts, 30 parts, 50 parts or a range between the two. More preferably, the windproof material is 15 parts by weight.

[0057] As a preferred embodiment, the Six Gods Soup is selected from any value or range between 15 and 35 parts by weight; Preferably, the six-ingredient formula is selected from any value or range between 15 and 35 parts by weight, specifically from: 15 parts, 18 parts, 20 parts, 22 parts, 25 parts, 28 parts, 30 parts, 32 parts, 35 parts or a range between the two. More preferably, the six-ingredient formula is selected from any value or range between 15 and 35 parts by weight, specifically from: 15 parts, 20 parts, 25 parts, 30 parts, 35 parts or a range between the two. More preferably, the six-ingredient formula is selected from any value or range between 15 and 35 parts by weight, specifically from 15 parts, 20 parts, 35 parts or a range between the two. More preferably, the Six Gods Soup is 35 parts by weight.

[0058] As a preferred embodiment, the silkworm pupae are selected from any value or range between 20 and 40 parts by weight; Preferably, the silkworm pupae are selected from any value or range between 20 and 40 parts by weight, specifically from: 20 parts, 22 parts, 25 parts, 28 parts, 30 parts, 32 parts, 35 parts, 38 parts, 40 parts or a range between the two. More preferably, the silkworm pupae are selected from any value or range between 20 and 40 parts by weight, specifically from: 20 parts, 25 parts, 30 parts, 35 parts, 40 parts or a range between the two. More preferably, the silkworm pupae are selected from any value or range between 20 and 40 parts by weight, specifically from 20 parts, 30 parts, 40 parts or a range between the two. More preferably, the silkworm pupae are 40 parts by weight.

[0059] As a preferred embodiment, the licorice is selected from any value or range between 10 and 25 parts by weight; Preferably, the licorice is selected from any value or range between 10 and 25 parts by weight, specifically from: 10 parts, 12 parts, 15 parts, 18 parts, 20 parts, 22 parts, 23 parts, 25 parts or a range between the two. More preferably, the licorice is selected from any value or range between 10 and 25 parts by weight, specifically from: 10 parts, 15 parts, 20 parts, 25 parts or a range between the two. More preferably, the licorice is selected from any value or range between 10 and 25 parts by weight, specifically from 10 parts, 15 parts, 25 parts or a range between the two. More preferably, the licorice is 25 parts by weight.

[0060] Preferably, the weight ratio of honeysuckle, forsythia, gardenia and red peony is selected from any value or range between 4-16:8-18:4-8:2-4; More preferably, the weight ratio of honeysuckle, forsythia, gardenia and red peony is selected from any value or range between 4-16:8-18:4-8:2-4, specifically from: 4:8:4:2, 4:8:8:4, 12:13:6:2, 16:18:4:3, 16:18:8:4 or a range between the two. More preferably, the weight ratio of honeysuckle, forsythia, gardenia and red peony is selected from any value or range between 4-16:8-18:4-8:2-4, specifically from: 4:8:8:4, 12:13:6:2, 16:18:4:3 or a range between the two. In a further preferred embodiment, the weight ratio of honeysuckle, forsythia, gardenia and red peony is 4:8:8:4.

[0061] Preferably, the bitter almonds are roasted bitter almonds.

[0062] Preferably, the Liushenqu is fried Liushenqu.

[0063] In the most preferred embodiment, the traditional Chinese medicine composition comprises the following components by weight: Honeysuckle 20 parts, Forsythia 40 parts, Isatis root 40 parts, Peppermint 50 parts, Bupleurum 40 parts, Burdock fruit 10 parts, Schizonepeta spike 40 parts, Gypsum 10 parts, Scutellaria baicalensis 60 parts, Gardenia 40 parts, Platycodon grandiflorus 40 parts, Red peony root 20 parts, Phragmites communis rhizome 75 parts, Fried bitter almond 10 parts, Lophatherum gracile 40 parts, Citrus aurantium 40 parts, Saposhnikovia divaricata 15 parts, Fried Shenqu 35 parts, Bombyx mori 40 parts, and Licorice 25 parts.

[0064] Secondly, the present invention provides a method for preparing the above-mentioned oral liquid. The method includes the following steps: weighing the raw materials in parts by weight; soaking honeysuckle, forsythia, schizonepeta, peppermint, immature bitter orange, and bupleurum in water; extracting the volatile oil using steam distillation; collecting the volatile oil and the distilled aqueous solution separately for later use; mixing the distilled residue with the remaining fourteen raw materials, decocting with water, filtering, combining the filtrates, and concentrating to obtain a clear extract 1; stirring the clear extract 1 with ethanol, allowing it to stand for alcohol precipitation, filtering, and concentrating the filtrate to obtain a clear extract 2; mixing the volatile oil, the distilled aqueous solution, and clear extract 2 to obtain the oral liquid.

[0065] Preferably, the method for preparing the oral liquid is as follows: (1) Weigh the raw materials as described above: honeysuckle, forsythia, isatis root, peppermint, bupleurum, burdock fruit, schizonepeta spike, gypsum, scutellaria, gardenia, platycodon, red peony root, reed rhizome, stir-fried bitter almond, light bamboo leaf, immature bitter orange peel, saposhnikovia root, stir-fried medicated leaven, silkworm, licorice. (2) Add 6 times the amount of ultrapure water to the raw materials of honeysuckle, forsythia, schizonepeta, peppermint, bitter orange peel and bupleurum, soak for 30 minutes, and extract the volatile oil by steam distillation. During the distillation process, collect the volatile oil and the distilled aqueous solution separately for later use. (3) Mix the distilled residue with the remaining fourteen raw materials, add 6 times the amount of ultrapure water and decoct. After boiling, continue to decoct for 1.5 hours. Filter the extract with 8 layers of gauze. Add 4 times the amount of ultrapure water to the residue and shake well. After boiling, continue to decoct for 1 hour. Filter the extract with 8 layers of gauze. After decoction, combine the decoctions, filter to remove impurities, and concentrate the filtrate to obtain clear extract 1. Control the concentration to a relative density of 1.05. Slowly add 95% ethanol to the clear extract 1 that has been concentrated and cooled to room temperature. Stir evenly. Stop adding ethanol when the alcohol content of the supernatant reaches 70%. Let stand and perform alcohol precipitation to further purify the effective components. After alcohol precipitation, filter and collect the filtrate. Concentrate again to clear extract 2 with a relative density of 1.05. Add the extracted volatile oil and the distilled aqueous solution to the concentrated clear extract 2 and mix thoroughly.

[0066] Thirdly, the present invention provides the application of the above-mentioned traditional Chinese medicine composition in the preparation of a pharmaceutical preparation for treating acute pharyngitis.

[0067] Fourthly, the present invention provides: a medicament for treating acute pharyngitis, comprising the above-mentioned traditional Chinese medicine composition and a pharmaceutically acceptable carrier, and / or a pharmaceutically acceptable excipient.

[0068] Preferably, the active ingredient in the drug includes geniposide.

[0069] Preferably, the active ingredient in the drug includes paeoniflorin.

[0070] Preferably, the dosage form of the drug is an oral preparation.

[0071] Preferably, the oral preparation is a capsule, tablet, oral liquid, honey pill, water drop pill, ointment, powder, or granule.

[0072] More preferably, the oral preparation is an oral liquid.

[0073] Preferably, the pharmaceutically acceptable carrier and / or pharmaceutically acceptable excipient are selected from one or more of solvents, flavoring agents, preservatives, fillers, disintegrants, lubricants, binders, and penetration enhancers; More preferably, the pharmaceutically acceptable carrier and / or pharmaceutically acceptable excipient is a solvent.

[0074] Preferably, the solvent is ultrapure water.

[0075] Fifthly, the present invention provides: an oral liquid for treating acute pharyngitis, comprising the above-mentioned traditional Chinese medicine composition and a pharmaceutically acceptable carrier, and / or a pharmaceutically acceptable excipient.

[0076] The oral liquid prepared according to the specific embodiments of the present invention contains 1-3g of Chinese medicinal materials (raw amount) per mL; The preferred concentration is 2g of Chinese medicinal materials (raw amount) per mL.

[0077] Preferably, the active ingredient in the oral liquid includes geniposide.

[0078] As a preferred embodiment, the content of geniposide is selected from any value or range between 1.212 and 1.991 mg / mL; Preferably, the content of geniposide is selected from any value or range between 1.212 and 1.991 mg / mL, specifically from: 1.212 mg / mL, 1.314 mg / mL, 1.4 mg / mL, 1.449 mg / mL, 1.579 mg / mL, 1.652 mg / mL, 1.785 mg / mL, 1.856 mg / mL, 1.951 mg / mL, 1.991 mg / mL, or a range between two of these. More preferably, the content of geniposide is selected from any value or range between 1.212 and 1.991 mg / mL, specifically from: 1.212 mg / mL, 1.314 mg / mL, 1.449 mg / mL, 1.579 mg / mL, 1.652 mg / mL, 1.856 mg / mL, 1.951 mg / mL, 1.991 mg / mL, or a range between the two. More preferably, the content of geniposide is selected from any value or range between 1.212 and 1.991 mg / mL, specifically from: 1.212 mg / mL, 1.314 mg / mL, 1.579 mg / mL, 1.856 mg / mL, 1.991 mg / mL or a range between the two; More preferably, the content of geniposide is selected from any value or range between 1.212 and 1.991 mg / mL, specifically from: 1.212 mg / mL, 1.579 mg / mL, 1.991 mg / mL or a range between the two; More preferably, the content of geniposide is 1.991 mg / mL.

[0079] Preferably, the active ingredient in the oral liquid includes paeoniflorin.

[0080] Preferably, the content of paeoniflorin is selected from any value or range between 0.591 and 0.824 mg / mL, specifically from: 0.591 mg / mL, 0.605 mg / mL, 0.621 mg / mL, 0.652 mg / mL, 0.682 mg / mL, 0.702 mg / mL, 0.721 mg / mL, 0.774 mg / mL, 0.805 mg / mL, 0.824 mg / mL, or a range between two of these. More preferably, the content of paeoniflorin is selected from any value or range between 0.591 and 0.824 mg / mL, specifically from: 0.591 mg / mL, 0.605 mg / mL, 0.621 mg / mL, 0.682 mg / mL, 0.774 mg / mL, 0.805 mg / mL, 0.824 mg / mL or a range between the two; More preferably, the content of paeoniflorin is selected from any value or range between 0.591 and 0.824 mg / mL, specifically from: 0.591 mg / mL, 0.621 mg / mL, 0.682 mg / mL, 0.805 mg / mL, 0.824 mg / mL or a range between the two; More preferably, the content of paeoniflorin is selected from any value or range between 0.591 and 0.824 mg / mL, specifically from: 0.591 mg / mL, 0.682 mg / mL, 0.824 mg / mL or a range between the two; More preferably, the content of paeoniflorin is 0.824 mg / mL.

[0081] Preferably, the dosage of the traditional Chinese medicine composition is selected from any value or range between 15-60 g / kg / day; More preferably, the dosage of the traditional Chinese medicine composition is selected from any value or range between 15-60 g / kg / day, specifically from: 15 g / kg / day, 20 g / kg / day, 25 g / kg / day, 30 g / kg / day, 35 g / kg / day, 40 g / kg / day, 45 g / kg / day, 50 g / kg / day, 55 g / kg / day, 60 g / kg / day or a range between the two. More preferably, the dosage of the traditional Chinese medicine composition is selected from any value or range between 15-60 g / kg / day, specifically from: 15 g / kg / day, 25 g / kg / day, 30 g / kg / day, 35 g / kg / day, 40 g / kg / day, 45 g / kg / day, 60 g / kg / day or a range between the two. More preferably, the dosage of the traditional Chinese medicine composition is selected from any value or range between 15-60 g / kg / day, specifically from: 15 g / kg / day, 30 g / kg / day, 45 g / kg / day or a range between the two. More preferably, the dosage of the traditional Chinese medicine composition is 45g / kg / day.

[0082] Based on further solutions to the technical problems of the present invention, or simultaneous solutions to multiple technical problems, the preferred solution in the technical solution provided in the first aspect of the present invention includes: The first priority solution is a traditional Chinese medicine composition for treating acute pharyngitis. This solution, having already addressed the technical issue of "not suitable for long-term use," further addresses the technical issues of "not suitable for sensitive individuals and easily damaging the spleen and stomach."

[0083] The second priority option is an oral liquid for treating acute pharyngitis. This technical solution, while addressing the technical problem of "treating acute pharyngitis," further resolves the technical issues of "unsuitability for long-term use, unsuitability for sensitive individuals, and potential damage to the spleen and stomach."

[0084] The beneficial effects of this invention are as follows: The present invention has at least the following beneficial effects: 1. This invention is primarily composed of pure herbal medicines. All twenty medicinal materials are sourced from the *Pharmacopoeia of the People's Republic of China* (19 ingredients) and *Chinese Materia Medica* (1 ingredient: Liu Shen Qu), and none are listed in their respective lists of toxic medicinal materials and processed medicinal slices. Among them, eleven ingredients—peppermint, red peony root, bamboo leaf, licorice root, honeysuckle, platycodon root, bitter almond, reed rhizome, burdock fruit, gardenia fruit, and immature bitter orange—are listed in the *List of Items That Are Both Food and Medicine* and the *List of Items That Can Be Used in Health Foods* published by the National Health Commission. In terms of processing, stir-frying Liu Shen Qu harmonizes the medicinal properties and protects the spleen and stomach, making it more suitable for long-term or sensitive individuals. Stir-frying bitter almond reduces toxicity.

[0085] 2. The oral liquid prepared by this invention can inhibit PGE2 expression, reduce changes in pharyngeal tissue structure, and improve inflammatory cell infiltration, lamina propria hemorrhage, and mucosal epithelial hyperplasia.

[0086] 3. The oral solution prepared in this invention can reduce the mRNA expression levels of IL-6 and IL-1β and inhibit the phosphorylation of serine / threonine protein kinase (AKT) and mitogen-activated protein kinase (MAPK) proteins. Attached Figure Description

[0087] Figure 1 The values ​​represent the white blood cell counts of rats in different groups, where # represents the difference between the model group and the control group, and * represents the difference between each example group and the comparative example group and the example 1 group. #### The asterisk (*) represents p < 0.0001, ns represents no significant difference, * represents p < 0.05, ** represents p < 0.01, and *** represents p < 0.001.

[0088] Figure 2 The numbers represent the number of rat mononuclear cells in different groups, where # represents the difference between the model group and the control group, and * represents the difference between each example group and the comparative example group and the example 1 group. ## The value represents p < 0.01, ns represents no significant difference, * represents p < 0.05, ** represents p < 0.01, and *** represents p < 0.001.

[0089] Figure 3 The values ​​represent the number of monocytes in rats from different groups, where # represents the difference between the model group and the control group, and * represents the difference between each example group and the comparative example group and the example 1 group. ## The asterisk (*) represents p < 0.01, ns represents no significant difference, * represents p < 0.05, and ** represents p < 0.01.

[0090] Figure 4 The values ​​represent the serum PEG2 content of rats in different groups, where # represents the difference between the model group and the control group, and * represents the difference between each example group and the comparative example group and the Example 1 group. ####The asterisk (*) represents p < 0.0001, ns represents no significant difference, * represents p < 0.05, ** represents p < 0.01, *** represents p < 0.001, and **** represents p < 0.0001.

[0091] Figure 5 The effects of different doses of the oral solution prepared in Example 1 on rat body weight and blood cell count. # * indicates the difference between MX and NC, and * indicates the difference between each treatment group and the MX group. ### * represents p<0.001, * represents p<0.05, ** represents p<0.01, *** represents p<0.001, and **** represents p<0.0001.

[0092] Figure 6 The effect of different doses of the oral solution prepared in Example 1 on the serum prostaglandin E2 content in rats is shown, where # represents the difference between MX and NC, and * represents the difference between each treatment group and the MX group. #### **** represents p<0.0001.

[0093] Figure 7 The effects of different doses of the oral solution prepared in Example 1 on the pathological changes of pharyngeal tissue in rats with acute pharyngitis.

[0094] Figure 8 The effects of different doses of drug-containing serum on the expression levels of IL-6 and IL-1β mRNA in THP-1 cells were investigated. Figure 8 A represents the IL-6 mRNA expression level in THP-1 cells at different doses of drug-containing serum; Figure 8 B represents the IL-1β mRNA expression levels in THP-1 cells at different doses of drug-containing serum, where... # * indicates the difference between the LPS group and the control group; * indicates the difference between each treatment group and the LPS group. #### ** represents p<0.0001, ** represents p<0.01, *** represents p<0.001, and **** represents p<0.0001.

[0095] Figure 9 The effects of different doses of drug-containing serum on the phosphorylation levels of AKT and MAPK were investigated. Figure 9 A represents the experimental results of Western blotting. Figure 9 B represents the phosphorylation levels of AKT and MAPK proteins, where * indicates the difference between each drug administration group and the LPS group, * indicates p<0.05, and *** indicates p<0.001. Detailed Implementation

[0096] The following non-limiting embodiments are intended to enable those skilled in the art to gain a more comprehensive understanding of the present invention, but do not limit the invention in any way. The following content is merely an exemplary description of the scope of protection claimed by the present invention, and those skilled in the art can make various changes and modifications to the present invention based on the disclosed content, and such changes should also fall within the scope of protection claimed by the present invention.

[0097] The present invention will be further described below by way of specific embodiments. Unless otherwise specified, all instruments, devices, equipment, reagents, products, etc., used in the embodiments of the present invention are obtained through conventional commercial means.

[0098] In this invention, the number of portions and weight can be converted to each other, i.e., 1 portion = 1g.

[0099] Table 1

[0100] Examples 1-3: An oral liquid for treating acute pharyngitis The prescriptions are based on parts by weight, as shown in Table 2.

[0101] Table 2

[0102] Preparation method of Example 1: (1) Weigh the raw materials as described above: honeysuckle, forsythia, isatis root, peppermint, bupleurum, burdock fruit, schizonepeta spike, gypsum, scutellaria, gardenia, platycodon, red peony root, reed rhizome, stir-fried bitter almond, light bamboo leaf, immature bitter orange peel, saposhnikovia root, stir-fried medicated leaven, silkworm, licorice. (2) Add 6 times the amount of ultrapure water to the raw materials of honeysuckle, forsythia, schizonepeta, peppermint, bitter orange peel and bupleurum, soak for 30 minutes, and extract the volatile oil by steam distillation. During the distillation process, collect the volatile oil and the distilled aqueous solution separately for later use. (3) Mix the distilled residue with the remaining fourteen raw materials, add 6 times the amount of ultrapure water and decoct. After boiling, continue to decoct for 1.5 hours. Filter the extract with 8 layers of gauze. Add 4 times the amount of ultrapure water to the residue and shake well. After boiling, continue to decoct for 1 hour. Filter the extract with 8 layers of gauze. After decoction, combine the decoctions, filter to remove impurities, and concentrate the filtrate to obtain clear extract 1. Control the concentration to a relative density of 1.05. Slowly add 95% ethanol to the clear extract 1 that has been concentrated and cooled to room temperature. Stir evenly. Stop adding ethanol when the alcohol content of the supernatant reaches 70%. Let stand and perform alcohol precipitation to further purify the effective components. After alcohol precipitation, filter and collect the filtrate. Concentrate again to clear extract 2 with a relative density of 1.05. Add the extracted volatile oil and the distilled aqueous solution to the concentrated clear extract 2 and mix evenly to obtain the final product.

[0103] The oral liquid contains 2g of Chinese medicinal materials (crude drug amount) per milliliter, with 1.991mg / mL of geniposide and 0.824mg / mL of paeoniflorin.

[0104] Preparation method of Example 2: Except for the amount of material fed, everything else is the same as in Example 1.

[0105] The oral liquid contains 2g of Chinese medicinal materials per milliliter, with 1.579mg / mL of geniposide and 0.591mg / mL of paeoniflorin.

[0106] Preparation method of Example 3: Except for the amount of material fed, everything else is the same as in Example 1.

[0107] The oral liquid contains 2g of Chinese medicinal materials per milliliter, with 1.212mg / mL of geniposide and 0.682mg / mL of paeoniflorin.

[0108] Comparative Example 1 The difference from Example 1 is that the weight parts of gardenia and red peony are changed, with gardenia being 15 parts and red peony being 18 parts, while the rest are the same as in Example 1.

[0109] In this comparative example, the content of geniposide was 1.031 mg / mL, and the content of paeoniflorin ranged from 0.722 mg / mL.

[0110] Comparative Example 2 The difference from Example 1 is that the weight ratios of gardenia and red peony are changed, with gardenia being 30 parts and red peony being 3 parts, while the rest are the same as in Example 1.

[0111] In this comparative example, the content of geniposide was 1.539 mg / mL and the content of paeoniflorin was 0.321 mg / mL.

[0112] Comparative Example 3 The difference from Example 1 is that the weight ratios of gardenia and red peony are changed, with gardenia being 10 parts and red peony being 4 parts, while the rest are the same as in Example 1.

[0113] In this comparative example, the content of geniposide was 0.823 mg / mL, and the content of paeoniflorin was 0.435 mg / mL.

[0114] Comparative Example 4 The difference from Example 1 is that the weight parts of gardenia and red peony are changed, with gardenia being 40 parts and red peony being 30 parts, while the rest are the same as in Example 1.

[0115] In this comparative example, the content of geniposide was 1.998 mg / mL and the content of paeoniflorin was 0.975 mg / mL.

[0116] Comparative Example 5 The difference from Example 1 is that the weight parts of gardenia and red peony and the content of gardenia and paeoniflorin are changed. Gardenia is 15 parts and red peony is 4.5 parts. All other parts are the same as in Example 1.

[0117] In this comparative example, the content of geniposide was 1.081 mg / mL and the content of paeoniflorin was 0.531 mg / mL.

[0118] Comparative Example 6 The difference from Example 1 is that red peony root is replaced with peony bark, otherwise it is the same as Example 1.

[0119] Comparative Example 7 The difference from Example 1 is that gardenia is replaced with coptis, otherwise it is the same as Example 1.

[0120] Comparative Example 8 The difference from Example 1 is that Paeonia lactiflora is replaced with Paeonia suffruticosa and Gardenia jasminoides is replaced with Coptis chinensis, while the rest are the same as in Example 1.

[0121] Comparative Examples 9-10 The difference from Example 1 is that the proportions of honeysuckle, forsythia, gardenia, and red peony were changed. The specific weight parts of each herbal component are shown in Table 3. Table 3

[0122] Everything else is the same as in Example 1.

[0123] Detection Example 1 1. Experimental Materials and Methods 1.1 Experimental Materials: (1) Animals: 4-5 week old SD rats were purchased from Spiford (Beijing) Biotechnology Co., Ltd.; (2) Drugs: ammonia water, oral liquids prepared in Examples 1-3 and Comparative Examples 1-10.

[0124] 1.2 Experimental Methods (1) Grouping: control group, model group, example 1 group, example 2 group, example 3 group, comparative example 1 group, comparative example 2 group, comparative example 3 group, comparative example 4 group, comparative example 5 group, comparative example 6 group, comparative example 7 group, comparative example 8 group, comparative example 9 group, comparative example 10 group.

[0125] (2) Modeling: 150 SD rats, half male and half female, were selected and fed acclimatized for 7 days. Except for the control group, 25% ammonia water was sprayed into the pharynx of the rats in the model group using a laryngeal sprayer, 3 puffs / time, 2 times / day, for 3 consecutive days to establish an acute pharyngitis model. The control group and the rats sprayed with purified water were used as controls.

[0126] (3) Drug administration: 150 SD rats, half male and half female, were randomly divided into control group, model group, Example 1 group, Example 2 group, Example 3 group, Comparative Example 1 group, Comparative Example 2 group, Comparative Example 3 group, Comparative Example 4 group, Comparative Example 5 group, Comparative Example 6 group, Comparative Example 7 group, Comparative Example 8 group, Comparative Example 9 group, and Comparative Example 10 group, with 10 SD rats in each group. Starting from the fourth day, each drug administration group was given the corresponding drug by gavage at a dose of 30g / kg / day, while the control group and model group were given an equal volume of purified water by gavage.

[0127] (4) Experimental method: After the last administration, the rats were fasted but allowed to drink water for 12 h. After anesthesia, 1 mL of blood was collected from the abdominal aorta into a blood collection tube containing anticoagulant. The number of white blood cells, lymphocytes, monocytes and granulocytes was detected in a blood cell analyzer. The remaining blood was collected and allowed to stand at room temperature for 30 min, centrifuged at 3000 r / min for 15 min, and the supernatant was collected. The serum PGE2 level was detected by enzyme-linked immunosorbent assay (ELISA).

[0128] 2. Experimental Results The pharmaceutical composition formulation of the present invention has a significant therapeutic effect on ammonia-induced acute pharyngitis in young rats. Compared with Comparative Examples 1-10, the oral liquid for treating acute pharyngitis prepared in Examples 1-3 can significantly reduce the number of white blood cells, monocytes, granulocytes and the content of PEG2 in the serum of rats.

[0129] The oral liquids prepared in Examples 1-3 of this invention showed significant improvement in multiple inflammatory markers, including reducing the number of white blood cells, monocytes, and granulocytes, and inhibiting the expression of the inflammatory mediator PGE2, indicating that they have a clear anti-inflammatory effect. Example 1 showed the best effect, demonstrating that the specific formulation, content, and specific ratio of honeysuckle, forsythia, gardenia, and red peony can more effectively regulate the inflammatory response.

[0130] Detection Example 2 1. Experimental Materials and Methods (1) Animals: 4-5 week old SD rats were purchased from Spiford (Beijing) Biotechnology Co., Ltd.; (2) Drugs: amoxicillin, ammonia, and the oral solution prepared in Example 1.

[0131] 1.2 Experimental Methods (1) Grouping: blank group (NC group), model group (MX group), amoxicillin group, low-dose group of oral liquid prepared in Example 1 (XE-L group), medium-dose group of oral liquid prepared in Example 1 (XE-M group), and high-dose group of oral liquid prepared in Example 1 (XE-H group).

[0132] (2) Modeling: Sixty SD rats, half male and half female, were selected and fed acclimatized for 7 days. Except for the blank group (NC group), 25% ammonia water was sprayed into the pharynx of the rats in the modeling group using a laryngeal sprayer, 3 puffs / time, 2 times / day, for 3 consecutive days to establish an acute pharyngitis model. The blank group (NC group) was sprayed with purified water as a control.

[0133] (3) Drug administration: Sixty SD rats, half male and half female, were randomly divided into blank group (NC group), model group (MX group), amoxicillin group, low-dose group of oral liquid prepared in Example 1 (XE-L group), medium-dose group of oral liquid prepared in Example 1 (XE-M group), and high-dose group of oral liquid prepared in Example 1 (XE-H group), with 10 SD rats in each group. Starting from the fourth day, the XE-L group, XE-M group, and XE-H group were administered 15g / kg / day, 30g / kg / day, and 45g / kg / day of the drug by gavage, respectively. The amoxicillin group was administered the clinically equivalent dose of 300mg / kg / day by gavage once a day for 5 consecutive days. The control group and model group were administered the same volume of purified water by gavage.

[0134] (4) Experimental methods: (4.1) Body weight: The body weight of each rat was recorded on days 1, 3, 5, 7 and 9 of the experiment.

[0135] (4.2) Blood cell analysis: After the experiment ended on the 9th day, 1 mL of blood was drawn from the abdominal aorta after anesthesia and placed in a blood collection tube containing anticoagulant. The blood cell count, monocyte count, and neutrophil count were then tested in a blood cell analyzer. (4.3) Detection of serum PGE2 level: Take the remaining blood and let it stand at room temperature for 30 min, centrifuge at 3000 r / min for 15 min, take the supernatant, and detect the serum PGE2 level by enzyme-linked immunosorbent assay (ELISA).

[0136] (4.4) Hematoxylin-eosin staining (HE): After blood collection, the rats were euthanized by dislocation of the cervical vertebrae. The trachea and esophagus were immediately cut at the level of the cricoid cartilage. The posterior pharyngeal wall tissue was taken, fixed with 4% paraformaldehyde, embedded in paraffin, and sectioned using a tissue sectioner to a thickness of 4 mm. Then, the sections were baked, dewaxed, rehydrated, and stained with HE. After mounting, the sections were observed and photographed under a microscope.

[0137] 2. Experimental Results On day 3 of the experiment, the body weight of rats in the model group decreased significantly (P < 0.001); after administration, the body weight of rats in all groups increased. Blood cell analysis detected the number of inflammation-related cells in the blood of rats in each group. Compared with the control group, the number of white blood cells, monocytes, and neutrophils in the blood of rats in the model group was significantly increased (P < 0.01); compared with the model group, the number of white blood cells, monocytes, and neutrophils in rats in the XE-L, XE-M, and XE-H groups was significantly decreased (P < 0.01), and this decrease was dose-dependent. Compared with the model group, the serum PGE2 level in rats in the XE-L, XE-M, and XE-H groups was significantly decreased after administration (p < 0.0001). PGE2 is a crucial lipid metabolite in the body, playing an important role in fever, inflammation, and blood pressure regulation. The oral liquid prepared in this invention can inhibit PGE2 expression, thereby alleviating symptoms such as fever and sore throat caused by acute pharyngitis.

[0138] The pharyngeal tissue structure of the model group rats was blurred, filled with a large number of inflammatory cells and mucosal epithelial hyperplasia. The changes in pharyngeal tissue structure in the XE-H group and the amoxicillin group rats were significantly reduced, with marked improvement in inflammatory cell infiltration, lamina propria hemorrhage, and mucosal epithelial hyperplasia, essentially approaching the level of the blank control group. The XE-L group and the XE-M group rats showed varying degrees of improvement in pharyngeal tissue structure, inflammatory cell infiltration, and mucosal epithelial hyperplasia. This indicates that the invented drug composition can improve inflammatory cell infiltration caused by acute pharyngitis, with the highest dose showing the best effect.

[0139] Detection Example 3 1. Experimental Materials and Methods (1) Experimental materials: lipopolysaccharide, Trizol, TransScript one-step gDNA removal and first-strand cDNA synthesis kit, TB Green® Premix Ex Taq™ (Tli RNaseH Plus), BeyoPure™ Ultrapure Water (DNase / RNase-Free, Sterile), Phospho-Akt antibody (Ser473) (3787S), Akt antibody (9272), Phospho-p44 / 42 MAPK (Erk1 / 2) (Thr202 / Tyr204) antibody, p44 / 42 MAPK (Erk1 / 2) antibody, β-Actin antibody (66009-1-Ig), murine secondary antibody (SA00001-1) and rabbit secondary antibody (SA00001-2).

[0140] (2) Experimental methods: Twenty female Wistar rats, weighing 200-220g, were randomly divided into two groups (blank group and Example 1 group) after acclimatization for 3 days, with 10 rats in each group. Example 1 group was administered the drug at 30g / kg / day, while the blank group was given the same volume of distilled water. All rats in each group were administered the drug for 1 week. Blood was collected from the abdominal aorta 2 hours after the last administration. After standing at room temperature for 2 hours, serum was separated under sterile conditions (centrifuged at 3000r / min for 15min). After filtration and sterilization, the serum was dispensed into 1.5mL EP tubes to obtain blank serum and drug-containing serum, which were stored at -80℃ for later use.

[0141] (3.1) Grouping: The experiment was divided into control group, LPS group, 2%XF group, 5%XF group and 10%XF group.

[0142] (3.2) Induction of macrophage inflammation model: THP-1 cells in good growth condition were collected and divided into groups of 1×10⁻⁶ cells each. 6 Cells were seeded in 6-well plates. The LPS group, 2%XF group, 5%XF group and 10%XF group were incubated with 1 μg / mL LPS for 24 h to induce macrophage inflammation model. Then, the 2%XF group, 5%XF group and 10%XF group were incubated with 2% drug-containing serum and 8% blank serum, 5% drug-containing serum and 5% blank serum, 10% drug-containing serum and 0% blank serum, respectively, for 24 h.

[0143] (3.3) Detection of IL-6 and IL-1β expression levels: RNA was extracted and qPCR experiments were performed to detect changes in the mRNA levels of related inflammatory factors IL-6 and IL-1β.

[0144] 2. Experimental Results Compared with the control group, the mRNA expression levels of IL-6 (p<0.0001) and IL-1β (p<0.0001) were significantly increased in the LPS group. Compared with the LPS group, the drug-containing serum in the treatment group could induce a concentration-dependent decrease in the mRNA expression levels of IL-6 and IL-1β. Specifically, 2% drug-containing serum could significantly induce a decrease in the expression level of IL-6 (p<0.001), and 5% drug-containing serum could effectively induce a decrease in the expression level of IL-1β (p<0.01), indicating that the drug composition has a good anti-inflammatory effect.

[0145] Detection Example 4 1. Experimental Materials and Methods (1) Experimental materials: drug-containing serum and blank serum prepared in Example 3, lipopolysaccharide, Phospho-Akt antibody (Ser473) (3787S), Akt antibody (9272), Phospho-p44 / 42 MAPK (Erk1 / 2) (Thr202 / Tyr204) antibody, p44 / 42 MAPK (Erk1 / 2) antibody, β-Actin antibody (66009-1-Ig), murine secondary antibody (SA00001-1) and rabbit secondary antibody (SA00001-2).

[0146] (2) Experimental method: According to 1×10 per group 6 THP-1 cells were seeded in 6-well plates and incubated for 6 h with blank control (CON), LPS group, 10% blank rat serum group (10%KB), and 10% drug-containing serum group (10%XF). Then, 1 μg / mL LPS was added to each group and incubated for 1 h. Proteins were extracted and Western blotting was performed to detect changes in phosphorylation levels of AKT and ERK proteins.

[0147] 2. Experimental Results Compared with the blank control group, the phosphorylation levels of AKT and MPAK proteins in the LPS group were significantly increased; compared with the LPS group, the phosphorylation levels of AKT and MAPK proteins in cells with 10% drug-containing serum were decreased (p<0.01), suggesting that the drug composition may inhibit the activation of the PI3K / AKT and RAS / MPAK pathways.

[0148] Finally, it should be noted that the above content is only used to illustrate the technical solution of the present invention, and is not intended to limit the scope of protection of the present invention. Simple modifications or equivalent substitutions made by those skilled in the art to the technical solution of the present invention do not depart from the essence and scope of the technical solution of the present invention.

Claims

1. A traditional Chinese medicine composition for treating acute pharyngitis, characterized in that, The composition by weight is as follows: 15-80 parts honeysuckle, 40-90 parts forsythia, 15-40 parts isatis root, 20-50 parts peppermint, 25-40 parts bupleurum, 10-45 parts burdock fruit, 25-40 parts schizonepeta spike, 10-60 parts gypsum, 35-60 parts scutellaria, 20-40 parts gardenia, 15-40 parts platycodon, 5-20 parts red peony root, 45-75 parts reed rhizome, 10-70 parts bitter almond, 15-40 parts light bamboo leaf, 15-40 parts immature bitter orange peel, 15-50 parts saposhnikovia root, 15-35 parts medicated leaven, 20-40 parts silkworm pupa, and 10-25 parts licorice; the weight ratio of honeysuckle, forsythia, gardenia to red peony root is 4-16:8-18:4-8:2-4.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The bitter almonds mentioned are roasted bitter almonds, and the Liushenqu mentioned is roasted Liushenqu.

3. The method for preparing the traditional Chinese medicine composition according to any one of claims 1-2, characterized in that, The steps include: weighing the raw materials by weight, soaking honeysuckle, forsythia, schizonepeta, peppermint, bitter orange peel, and bupleurum in water, extracting volatile oils by steam distillation, collecting the volatile oils and the distilled aqueous solution separately for later use; mixing the distilled residue with the remaining fourteen raw materials, decocting in water, filtering, combining the filtrates, concentrating to obtain clear extract 1; stirring the clear extract with ethanol, allowing it to stand for alcohol precipitation, filtering, and concentrating the filtrate to obtain clear extract 2; mixing the volatile oils, the distilled aqueous solution, and clear extract 2 to obtain the traditional Chinese medicine composition.

4. The use of the traditional Chinese medicine composition according to any one of claims 1-2 in the preparation of a pharmaceutical preparation for treating acute pharyngitis.

5. A drug for treating acute pharyngitis, characterized in that, The composition comprises the traditional Chinese medicine composition according to any one of claims 1-2 and a pharmaceutically acceptable carrier and / or a pharmaceutically acceptable excipient.

6. The drug according to claim 5, characterized in that, The active ingredient in the drug includes geniposide, and the content of geniposide is 1.212-1.991 mg / mL.

7. The drug according to claim 5, characterized in that, The active ingredient in the drug includes paeoniflorin, and the content of paeoniflorin is 0.591-0.824 mg / mL.

8. An oral liquid for treating acute pharyngitis, characterized in that, It comprises the traditional Chinese medicine composition according to any one of claims 1-2 and a pharmaceutically acceptable carrier, and / or a pharmaceutically acceptable excipient.

9. The oral liquid according to claim 8, characterized in that, The active ingredient includes geniposide, and the content of geniposide is 1.212-1.991 mg / mL; The active ingredient also includes paeoniflorin, and the content of paeoniflorin is 0.591-0.824 mg / mL.

10. The oral liquid according to claim 8, characterized in that, The dosage of the traditional Chinese medicine composition is 15-60 g / kg / day.

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