A traditional Chinese medicine composition for clearing heat and resolving toxins, benefiting the throat and reducing swelling, and a preparation method and use thereof

Abstract

The application discloses a traditional Chinese medicine composition for clearing heat and resolving toxins, benefiting the throat and eliminating swelling, and a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: Houttuynia cordata 10-20 parts, Astragalus root 8-15 parts, Andrographis 8-15 parts, Figwort 8-15 parts, Platycodon 8-15 parts, Monotropa 8-15 parts, Honeysuckle 2-6 parts, Bupleurum 2-6 parts, Belamcanda 2-6 parts, Peucedanum 2-6 parts, Marsh Marigold 1-4 parts and artificial ox gall 0.1-0.6 parts. The traditional Chinese medicine composition has the effects of clearing heat and resolving toxins, benefiting the throat and eliminating swelling, relieving cough and reducing sputum, and is used for treating fever caused by wind-heat invading the lung and lung heat being in excess, nasal discharge of sticky or yellow phlegm, sore throat, cough and expectoration, yellow and thick sputum, headache and body pain, red tongue and yellow tongue fur and the like, and is also used for treating influenza, acute upper respiratory tract infection, acute pharyngitis, tonsillitis and the like. The effect is better than that of each proportion.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition for clearing heat and detoxifying, relieving sore throat and reducing swelling, as well as its preparation method and uses. Background Technology

[0002] Pharyngitis is a nonspecific inflammation of the pharynx, a general term for inflammation caused by various microbial infections of the pharynx. It can exist alone, coexist with rhinitis, tonsillitis, and laryngitis, or be a prodromal symptom of certain diseases. It can be divided into acute pharyngitis and chronic pharyngitis. Acute pharyngitis is an acute inflammation of the pharyngeal mucosa and submucosal tissues, often involving the pharyngeal lymphoid tissue. In the early stages, the inflammation may be localized, but as the condition progresses, it often involves the entire pharyngeal cavity. It is more common in autumn and winter, and the transition from winter to spring. The main symptoms are dryness, burning, pain, significant pain when swallowing, and congestion and swelling of the pharynx. Chronic pharyngitis can be further divided into chronic simple pharyngitis, chronic hypertrophic pharyngitis, and atrophic pharyngitis. Chronic simple pharyngitis is the most common. The lesion is mainly in the mucosal layer, manifested as chronic congestion of the pharyngeal mucosa, hyperplasia of the mucosa and submucosal connective tissue, enlargement of the mucous glands, hypersecretion, and increased mucus secretion. Patients often cough up sticky phlegm in their throat, or feel a foreign body sensation in their throat that they cannot cough up or swallow. The causes of pharyngitis include: external pathogenic factors; such as wind-cold or wind-heat invading the throat; improper diet; excessive consumption of spicy, greasy, or irritating foods, or excessive alcohol consumption; emotional imbalance; depression, anxiety, etc.; and dysfunction of internal organs; such as dysfunction of the lungs, spleen, and kidneys.

[0003] Whether treating acute or chronic pharyngitis, Western medicine primarily uses antibiotics, antiviral drugs, and corticosteroids, such as cephalosporins, penicillin, and roxithromycin. While initial symptoms may improve, the symptoms often return to their previous state over time, and drug resistance can develop, leading to prolonged and difficult-to-cure conditions, along with various adverse reactions. Furthermore, antibiotics are ineffective in treating sore throats caused by viral infections and contribute to environmental antibiotic pollution.

[0004] Traditional Chinese medicine (TCM) treatment for pharyngitis primarily follows the principle of syndrome differentiation and treatment, selecting appropriate herbal formulas. Currently, proprietary Chinese medicines such as Lanqin Oral Liquid, Pudilan Anti-inflammatory Oral Liquid, and Compound Houttuynia Cordata Mixture are recommended as commonly used medications for treating acute pharyngitis. TCM therapy has shown unique advantages in dealing with acute illnesses, especially influenza and febrile diseases. Using TCM to treat these diseases has positive significance in replacing antibiotics and curbing drug resistance. Common TCM formulas for treating pharyngitis include: Yangyin Qingfei Decoction (Nourishing Yin and Clearing Lung Decoction), composed of Rehmannia glutinosa, Ophiopogon japonicus, and Scrophularia ningpoensis, which nourishes Yin and clears the lungs; Zhibai Dihuang Pill (Anemarrhena asphodeloides, Phellodendron chinense, and Rehmannia glutinosa), which nourishes Yin and reduces fire; Sangju Drink (Mulberry Leaf and Chrysanthemum), which dispels wind, clears heat, and soothes the throat; Yinqiao Powder (Honeysuckle and Forsythia suspensa), composed of Lonicera japonica and Forsythia suspensa, which clears heat and detoxifies; and Huanglian Shangqing Pill (Coptis chinensis), whose main ingredient is Coptis chinensis, which clears heat and drains fire. Traditional Chinese medicine (TCM) has fewer side effects in treating acute and chronic pharyngitis, and often achieves good results in relieving symptoms and reducing recurrence rates in chronic pharyngitis, addressing both the symptoms and the root cause. For example:

[0005] Chinese invention patent application CN118743742A discloses a traditional Chinese medicine composition for treating chronic pharyngitis. The composition is prepared from the following raw materials in parts by weight: 15-25 parts of Ophiopogon japonicus, 10-20 parts of Dioscorea opposita, 10-20 parts of American ginseng, 20-30 parts of Scrophularia ningpoensis, 5-15 parts of gypsum, 8-12 parts of Anemarrhena asphodeloides, 20-30 parts of Phragmites communis, and 15-25 parts of Lonicera japonica. The preparation method and uses are also disclosed. This invention achieves the purpose of treating chronic pharyngitis by nourishing the lungs and kidneys, clearing lung heat, soothing the liver and regulating qi, resolving phlegm, promoting body fluid production and moisturizing dryness, promoting blood circulation and removing blood stasis, and tonifying the spleen.

[0006] Chinese invention patent application CN118593626A discloses a traditional Chinese medicine composition for treating pharyngitis and its preparation method. The composition, by weight, is made from the following raw materials: 1-18 parts of Astilbe, 1-12 parts of *Trifolium repens*, 1-30 parts of *Solidago virgaurea*, 1-30 parts of Forsythia suspensa, 1-24 parts of Asparagus cochinchinensis, 1-21 parts of Ophiopogon japonicus, 1-30 parts of Scrophularia ningpoensis, 1-30 parts of Chrysanthemum indicum, 1-30 parts of Rehmannia glutinosa, 1-20 parts of Platycodon grandiflorus, and 1-20 parts of Glycyrrhiza uralensis. Astilbe, *Trifolium repens*, and *Solidago virgaurea* are the principal herbs; Scrophularia ningpoensis, Forsythia suspensa, and Chrysanthemum indicum are the assistant herbs; Rehmannia glutinosa, Ophiopogon japonicus, and Asparagus cochinchinensis are the adjuvant herbs; and Platycodon grandiflorus and Glycyrrhiza uralensis are the guiding herbs. This traditional Chinese medicine composition is suitable for acute pharyngitis, chronic pharyngitis, and tonsillitis, and has the effects of clearing heat and detoxifying, nourishing yin and reducing fire, dispersing nodules and reducing swelling, and clearing the throat.

[0007] Traditional Chinese medicine (TCM) books commonly classify pharyngitis into syndromes such as spleen qi deficiency, spleen and kidney yang deficiency, phlegm stagnation and blood stasis, and lung and kidney yin deficiency. However, this classification falls far short of capturing the complex and varied pathogenesis in clinical practice. Existing prescriptions for pharyngitis often employ a single treatment method, such as using Banxia Houpu Decoction to relieve stagnation, promote qi circulation, disperse phlegm, or use Kujiu Decoction to dispel pathogens, disperse stagnation, and reduce swelling; or using Jiegeng Decoction to clear heat, detoxify, and soothe the throat; or using Liuwei Dihuang Pills to nourish yin, tonify the kidneys, and soothe the throat. Overall, the current treatment outcomes for pharyngitis are not ideal. Summary of the Invention

[0008] To address the problems of tolerance to Western medicine in treating pharyngitis, the complexity of traditional Chinese medicine compositions, and the limited treatment methods in existing technologies, this invention provides a traditional Chinese medicine composition for clearing heat and detoxifying, relieving sore throat and reducing swelling, along with its preparation method and uses. Through the mutual compatibility and synergistic effect of the drugs, the efficacy is significantly improved, achieving both symptomatic and root-cause treatment.

[0009] To achieve the above objectives, the technical solution adopted by the present invention is as follows:

[0010] This invention provides a traditional Chinese medicine composition for clearing heat and detoxifying, relieving sore throat and reducing swelling. By weight, the traditional Chinese medicine composition is prepared from the following raw materials: 10-20 parts of Houttuynia cordata, 8-15 parts of Astragalus membranaceus, 8-15 parts of Andrographis paniculata, 8-15 parts of Scrophularia ningpoensis, 8-15 parts of Platycodon grandiflorus, 8-15 parts of Cypripedium lyratum, 2-6 parts of Lonicera japonica, 2-6 parts of Bupleurum chinense, 2-6 parts of Belamcanda chinensis, 2-6 parts of Peucedanum praeruptorum, 1-4 parts of Trollius chinensis, and 0.1-0.6 parts of artificial bezoar.

[0011] Preferably, the raw materials, by weight, are: 12-18 parts of Houttuynia cordata, 10-14 parts of Astragalus membranaceus, 10-14 parts of Andrographis paniculata, 10-14 parts of Scrophularia ningpoensis, 10-14 parts of Platycodon grandiflorus, 10-14 parts of Heliotropium indicum, 2-6 parts of Lonicera japonica, 2-6 parts of Bupleurum chinense, 2-6 parts of Belamcanda chinensis, 2-6 parts of Peucedanum praeruptorum, 1-4 parts of Trollius chinensis, and 0.2-0.4 parts of artificial bezoar.

[0012] Preferably, the weight ratio of Astragalus membranaceus to Bupleurum chinense is 8-15:2-6.

[0013] The present invention also provides a method for preparing the above-mentioned traditional Chinese medicine composition, comprising the following steps:

[0014] (1) Weigh out the following ingredients according to their weight proportions: Houttuynia cordata, Astragalus membranaceus, Andrographis paniculata, Scrophularia ningpoensis, Platycodon grandiflorus, Cynodon dactylon, Lonicera japonica, Bupleurum chinense, Belamcanda chinensis, Peucedanum praeruptorum, and Tropaeolum majus. Add water and decoct. Filter the mixture and concentrate the filtrate under reduced pressure to obtain extract 1.

[0015] (2) Add ethanol to extract 1, stir well, let stand, filter, and concentrate the filtrate under reduced pressure to obtain extract 2.

[0016] (3) After vacuum drying of extract 2, pulverize it and add artificial bezoar to obtain the traditional Chinese medicine composition.

[0017] Furthermore, in step (1), the amount of water added during the decoction is 6-10 times the total amount of raw materials, and the decoction is performed 1-4 times, with each decoction lasting 1-4 hours.

[0018] Further, in step (2), ethanol is added until the volume fraction of ethanol in the system is 50-95%.

[0019] Furthermore, the settling time mentioned in step (2) is 2-8 hours.

[0020] Furthermore, the relative densities of extract 1 and extract 2 are 1.10-1.30.

[0021] The present invention also provides a pharmaceutical preparation comprising the above-mentioned traditional Chinese medicine composition.

[0022] Furthermore, the pharmaceutical formulation also includes one or more pharmaceutically acceptable excipients and / or excipients.

[0023] Furthermore, the pharmaceutical preparation is an oral preparation.

[0024] Furthermore, the dosage form of the pharmaceutical preparation includes granules, decoctions, tablets, capsules, powders, pills, oral liquids, or syrups.

[0025] The present invention also provides the application of the above-mentioned traditional Chinese medicine composition or the traditional Chinese medicine composition or the above-mentioned preparation method in the preparation of drugs for clearing heat and detoxifying, relieving sore throat and reducing swelling.

[0026] Furthermore, the indications for the drug include common cold due to wind-heat, runny nose with sticky or yellow nasal discharge, sore throat, cough with phlegm, thick yellow phlegm, headache and body aches, red tongue with yellow coating, as well as influenza, upper respiratory tract infection, pharyngitis, tonsillitis, etc.

[0027] All raw medicinal materials used in the prescription of this invention meet the requirements of the Pharmacopoeia of the People's Republic of China (2020 Edition) (hereinafter referred to as the Pharmacopoeia). The medicinal properties and efficacy of each Chinese medicinal material are as follows:

[0028] Houttuynia cordata: Properties: pungent; cold; Liver meridian; Lung meridian; Main uses: clears heat and detoxifies, promotes diuresis and reduces swelling. Treats pneumonia, lung abscess, dysentery, malaria, edema, gonorrhea, leukorrhea, carbuncles, hemorrhoids, rectal prolapse, eczema, tinea capitis, and scabies. *Diannan Materia Medica*: Treats lung abscess with cough and purulent, bloody sputum, foul-smelling phlegm, intestinal heat toxicity, and hemorrhoids.

[0029] Astragalus membranaceus: Bitter in taste and cold in nature; attributive to the lung meridian, gallbladder meridian, spleen meridian, large intestine meridian, and small intestine meridian; main treatment: purging excessive fire, removing damp-heat, stopping bleeding, and preventing miscarriage. It is used to treat high fever with restlessness and thirst, cough due to lung heat, damp-heat diarrhea and dysentery, jaundice, heat strangury, vomiting, epistaxis, metrorrhagia, metrostaxis, red and swollen eyes, threatened abortion, carbuncles and furuncles. "Supplementary Records of Materia Medica": Treating phlegm-heat, heat in the stomach, colic in the lower abdomen, promoting digestion, benefiting the small intestine, amenorrhea in women, bloody vaginal discharge, and abdominal pain in children.

[0030] Andrographis paniculata: Bitter in taste and cold in nature; attributive to the heart, lung, large intestine, and bladder meridians. It has the effects of clearing heat and detoxifying, cooling blood and detumescence. It is used for colds with fever, sore throat, oral ulcers, whooping cough with cough, diarrhea and dysentery, heat strangury with pain, carbuncles and ulcers, and snake and insect bites.

[0031] Scrophularia ningpoensis: Sweet, bitter, and salty in taste, slightly cold in nature; attributive to the spleen, stomach, and kidney meridians; has the effects of clearing heat and cooling blood, nourishing yin and reducing fire, detoxifying and dissipating nodules; used for warm febrile diseases with heat invading nutrient-blood, fever of the body, restlessness and thirst, crimson tongue, maculae, consumptive fever with cough, vexation and insomnia due to deficiency, constipation due to fluid injury, blurred vision, sore throat, scrofula, phlegm nodules, carbuncles, and sores.

[0032] Platycodon grandiflorus: Bitter in taste; pungent; neutral in nature; attributive to the lung meridian and stomach meridian; main treatment: dispersing the lung qi, expelling phlegm and draining pus. It is used to treat exogenous cough, sore throat, lung abscess with expectoration, fullness in the chest and pain in the hypochondrium, and abdominal pain due to dysentery. "Supplementary Records of Materia Medica": Benefiting the five zang-organs and the stomach and intestines, tonifying qi and blood, dispelling cold and heat, wind-bi, warming the middle to promote digestion, and treating sore throat.

[0033] Archidendron clypearia: First recorded in "Compendium of Materia Medica" written by Li Shizhen in the Ming Dynasty, and also recorded in "Materia Medica of Lu Chuan" written by Zhao Xuemin in the Qing Dynasty. Its dried leafy stems can be used as medicine. It is slightly bitter and astringent in taste, slightly cold in nature, attributive to the spleen, stomach, and liver meridians, and has the effects of clearing heat and detoxifying, cooling blood and detumescence, stopping diarrhea, and removing dampness and astringing sores.

[0034] Lonicera japonica: Also known as honeysuckle, sweet and cold in taste, attributive to the lung, heart, and stomach meridians, and has the effects of anti-inflammatory and detoxifying, clearing the throat and relieving sore throat, etc. This medicine is often used to treat carbuncles and furuncles, wind-heat colds, febrile diseases with fever, etc.

[0035] Bupleurum chinense: The dried root of Bupleurum chinense DC. or Bupleurum scorzonerifolium Willd. of the Umbelliferae family. Pungent, bitter, slightly cold. It harmonizes the exterior and interior, soothes the liver and relieves depression, raises yang and relieves prolapse, reduces fever and arrests malaria. It is used for colds with fever, alternating chills and fever, distending pain in the chest and hypochondrium, irregular menstruation, uterine prolapse, and rectal prolapse.

[0036] Belamcanda chinensis: Bitter in taste; cold; bitter. Attributive to the lung and liver meridians. Clearing heat and detoxifying; resolving phlegm and relieving sore throat; removing stasis and dissipating nodules. Mainly treating sore throat; cough with dyspnea; scrofula; malaria mother and abdominal mass; carbuncles and sores.

[0037] Peucedanum praeruptorum: Bitter and pungent in taste, slightly cold in nature. Attributive to the lung meridian. It has the effects of lowering qi and resolving phlegm, dispersing wind and clearing heat. It is used for phlegm-heat dyspnea, expectoration of yellow and thick phlegm, and excessive phlegm in wind-heat cough.

[0038] Golden lotus: bitter in taste and cold in nature; it has the effects of clearing heat and detoxifying; it is used for upper respiratory tract infections, tonsillitis, pharyngitis, acute otitis media and other diseases; its main active ingredients are flavonoids and phenolic acids; it has pharmacological effects such as antioxidation, antibacterial, antiviral, anti-inflammatory, antitumor, antipyretic and analgesic.

[0039] Artificial bezoar: In traditional Chinese medicine, bezoar is considered to have a clear fragrance, a slightly bitter taste followed by sweetness, and a cool nature, entering the heart and liver meridians. It can be used to relieve fever, detoxify, and calm convulsions. Internally, it is used to treat high fever with delirium, mania, infantile convulsions, and spasms. Externally, it is used to treat sore throat, canker sores, and boils, and to treat poisoning. Artificial bezoar is made from a mixture of bovine bile powder, cholic acid, deoxycholic acid, taurine, bilirubin, cholesterol, trace elements, etc., and its components are known.

[0040] Golden buckwheat: Slightly pungent and astringent in taste, cool in nature, and enters the lung meridian. It has the effects of clearing heat and detoxifying, eliminating carbuncles and draining pus, resolving phlegm and relieving sore throat, and strengthening the spleen and promoting digestion. Golden buckwheat is particularly effective in treating lung abscesses with thick, foul-smelling sputum or coughing up pus and blood. It can be used for lung abscesses, scrofula, boils, snake bites, and dysentery. Its phlegm-resolving and soothing effects can be used for coughs due to lung heat and sore throat. Its spleen-strengthening and digestion-promoting effects can be used for abdominal distension, poor appetite, and malnutrition.

[0041] Both buckwheat and houttuynia cordata are heat-clearing and detoxifying herbs. Not only do their original plants look similar, but their effects and applications are also very similar.

[0042] Compared with the prior art, the beneficial effects that this invention can achieve are:

[0043] (1) The traditional Chinese medicine composition prepared in this invention has the effects of clearing heat and detoxifying, relieving sore throat and reducing swelling, relieving cough and resolving phlegm. It is mainly used to treat wind-heat colds, with symptoms of wind-heat invading the lungs and excessive lung heat, such as fever, runny nose with sticky or yellow nasal discharge, sore throat, cough with phlegm, thick yellow phlegm, headache and body aches, red tongue with yellow coating, etc., as well as influenza, acute upper respiratory tract infection, acute pharyngitis, tonsillitis and other diseases with the above symptoms. The prescription is not only uniquely conceived and has no obvious toxic side effects, but also has significant curative effect, achieving the effect of treating both the symptoms and the root cause, which helps to shorten the treatment cycle of patients and reduce the recurrence rate.

[0044] (2) This invention provides a traditional Chinese medicine composition for clearing heat and detoxifying, relieving sore throat and reducing swelling. Through scientific formulation, the synergistic effect of the extracted active ingredients helps to fully exert the therapeutic effect of the traditional Chinese medicine composition, and improves the utilization rate of the drug while ensuring efficacy.

[0045] (3) By replacing Houttuynia cordata with buckwheat, which has the same heat-clearing and detoxifying effects, this invention shows that the prescription of raw materials and mass fractions has a significant impact on efficacy. In addition, it demonstrates the synergistic effect of the combination of raw materials, especially Astragalus membranaceus and Bupleurum chinense. Animal in vivo test results show that it can significantly improve the effects of pharyngitis and fever, and can effectively solve the problem of single or unsatisfactory treatment effects of existing Chinese medicines. Attached Figure Description

[0046] Figure 1 The results of the antibacterial test of the traditional Chinese medicine composition in Example 1;

[0047] Figure 2 The images show HE-stained histopathological sections of the pharyngeal tissue of rats in each group of Experiment 2. A is the blank control group (intact pharyngeal epithelium, no inflammatory cell infiltration under the epithelium; HE×100); B is the model control group (pharyngeal epithelial necrosis, inflammatory exudate in the lumen, subepithelial vasodilation, inflammatory cell infiltration, tissue hemorrhage, and edema; HE×100); C is the positive control group of compound Houttuynia cordata mixture (subepithelial inflammatory cell infiltration, vasodilation and congestion in the pharyngeal epithelium; HE×100); and D is the traditional Chinese medicine composition of Example 1 (subepithelial inflammatory cell infiltration in the pharyngeal tissue; HE×100). Detailed Implementation

[0048] The present invention will be illustrated below with examples to make the technical solution of the present invention easier to understand and master, but the present invention is not limited thereto. Unless otherwise specified, the experimental methods described in the following examples are conventional methods; unless otherwise specified, the medicinal materials and reagents can be obtained commercially; and the performance of products from different sources does not have a significant impact.

[0049] When numerical ranges are given in the embodiments, it should be understood that, unless otherwise stated in the invention, both endpoints of each numerical range and any value between the two endpoints may be selected. Unless otherwise defined, all technical and scientific terms used in this invention have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains.

[0050] Unless otherwise specified, all chemical reagents and raw materials used in the embodiments of this invention are obtained through conventional commercial channels, and products from different manufacturers do not have a significant impact on the effect.

[0051] Example 1

[0052] The raw materials of the traditional Chinese medicine composition, by weight, are: 15 parts of Houttuynia cordata, 12 parts of Astragalus membranaceus, 12 parts of Andrographis paniculata, 12 parts of Scrophularia ningpoensis, 12 parts of Platycodon grandiflorus, 12 parts of Cypripedium sarmentosum, 4 parts of Lonicera japonica, 4 parts of Bupleurum chinense, 4 parts of Belamcanda chinensis, 4 parts of Peucedanum praeruptorum, 2.5 parts of Trollius chinensis and 0.35 parts of artificial bezoar.

[0053] The preparation method of the traditional Chinese medicine composition is as follows:

[0054] (1) Weigh out the raw materials Houttuynia cordata, Astragalus membranaceus, Andrographis paniculata, Scrophularia ningpoensis, Platycodon grandiflorus, Heliotropium indicum, Lonicera japonica, Bupleurum chinense, Belamcanda chinensis, Peucedanum praeruptorum and Trollius chinensis according to the weight proportions, add water with a total weight of 6 times the above raw materials and decoct once for 4 hours. Filter the decoction to obtain the filtrate, and concentrate it under reduced pressure to obtain an extract with a relative density of 1.10.

[0055] (2) Add ethanol to extract 1, stir evenly according to the alcohol content of 60% at the endpoint, let stand for 2 hours, filter to obtain filtrate, and concentrate under reduced pressure to extract 2 with a relative density of 1.30.

[0056] (3) After vacuum drying of extract 2, pulverize it and add artificial bezoar to obtain the traditional Chinese medicine composition.

[0057] Example 2

[0058] The raw materials of the traditional Chinese medicine composition, by weight, are: 10 parts of Houttuynia cordata, 8 parts of Astragalus membranaceus, 8 parts of Andrographis paniculata, 8 parts of Scrophularia ningpoensis, 8 parts of Platycodon grandiflorus, 8 parts of Cypripedium truncatum, 2 parts of Lonicera japonica, 2 parts of Bupleurum chinense, 2 parts of Belamcanda chinensis, 2 parts of Peucedanum praeruptorum, 1 part of Tropaeolum majus, and 0.1 parts of artificial bezoar.

[0059] The preparation method of the traditional Chinese medicine composition is as follows:

[0060] (1) Weigh out the raw materials Houttuynia cordata, Astragalus membranaceus, Andrographis paniculata, Scrophularia ningpoensis, Platycodon grandiflorus, Heliotropium indicum, Lonicera japonica, Bupleurum chinense, Belamcanda chinensis, Peucedanum praeruptorum, and Trollius chinensis according to the weight proportions. Add water to the above raw materials and decoct. Repeat the decoction with water on the filtered Chinese medicine residue. Filter and combine the obtained filtrates. Decoction for 2 hours each time. Concentrate the filtrate under reduced pressure to obtain an extract with a relative density of 1.20.

[0061] (2) Add ethanol to extract 1, stir evenly according to the alcohol content of 80% at the endpoint, let stand for 4 hours, filter to obtain filtrate, and concentrate under reduced pressure to extract 2 with a relative density of 1.30.

[0062] (3) After vacuum drying of extract 2, pulverize it and add artificial bezoar to obtain the traditional Chinese medicine composition.

[0063] Example 3

[0064] The raw materials of the traditional Chinese medicine composition, by weight, are: 20 parts of Houttuynia cordata, 15 parts of Astragalus membranaceus, 15 parts of Andrographis paniculata, 15 parts of Scrophularia ningpoensis, 15 parts of Platycodon grandiflorus, 15 parts of Cypripedium truncatum, 6 parts of Lonicera japonica, 6 parts of Bupleurum chinense, 6 parts of Belamcanda chinensis, 6 parts of Peucedanum praeruptorum, 4 parts of Trollius chinensis, and 0.6 parts of artificial bezoar.

[0065] The preparation method of the traditional Chinese medicine composition is as follows:

[0066] (1) Weigh out the raw materials Houttuynia cordata, Astragalus membranaceus, Andrographis paniculata, Scrophularia ningpoensis, Platycodon grandiflorus, Heliotropium indicum, Lonicera japonica, Bupleurum chinense, Belamcanda chinensis, Peucedanum praeruptorum, and Trollius chinensis according to the weight proportions. Add water in 10 times the total weight of the above raw materials and decoct. Repeat the decoction with water on the filtered Chinese medicine residue, filter, combine the obtained filtrates, decoct a total of 4 times, each time for 1 hour, and concentrate the filtrate under reduced pressure to form an extract with a relative density of 1.10.

[0067] (2) Add ethanol to extract 1, stir evenly to a final alcohol content of 95%, let stand for 8 hours, filter to obtain filtrate, and concentrate under reduced pressure to extract 2 with a relative density of 1.30.

[0068] (3) After vacuum drying of extract 2, pulverize it and add artificial bezoar to obtain the traditional Chinese medicine composition.

[0069] Example 4

[0070] The raw materials of the traditional Chinese medicine composition, by weight, are: 15 parts of Houttuynia cordata, 8 parts of Astragalus membranaceus, 15 parts of Andrographis paniculata, 8 parts of Scrophularia ningpoensis, 15 parts of Platycodon grandiflorus, 8 parts of Cypripedium truncatum, 6 parts of Lonicera japonica, 2 parts of Bupleurum chinense, 6 parts of Belamcanda chinensis, 2 parts of Peucedanum praeruptorum, 3 parts of Tropaeolum majus, and 0.2 parts of artificial bezoar.

[0071] The preparation method of the traditional Chinese medicine composition is as follows:

[0072] (1) Weigh out the raw materials Houttuynia cordata, Astragalus membranaceus, Andrographis paniculata, Scrophularia ningpoensis, Platycodon grandiflorus, Heliotropium indicum, Lonicera japonica, Bupleurum chinense, Belamcanda chinensis, Peucedanum praeruptorum, and Trollius chinensis according to the weight proportions. Add water to the above raw materials 8 times the total weight of the raw materials and decoct. The filtered Chinese medicine residue is repeatedly added to water and decocted. Filter and combine the obtained filtrates. Decoction is carried out twice, each time for 3 hours. The combined filtrates are concentrated under reduced pressure to form an extract with a relative density of 1.10.

[0073] (2) Add ethanol to extract 1, stir evenly according to the alcohol content of 50% at the endpoint, let stand for 5 hours, filter to obtain filtrate, and concentrate under reduced pressure to extract 2 with a relative density of 1.30.

[0074] (3) After vacuum drying of extract 2, pulverize it and add artificial bezoar to obtain the traditional Chinese medicine composition.

[0075] Example 5

[0076] Preparation of granules: Take the traditional Chinese medicine composition prepared in Example 1, pulverize it into fine powder, add an appropriate amount of sugar powder and dextrin, mix well, granulate with ethanol, dry and granulate to obtain granules.

[0077] Comparative Example 1

[0078] The raw materials of the traditional Chinese medicine composition, by weight, are: 12 parts Astragalus membranaceus, 12 parts Andrographis paniculata, 12 parts Scrophularia ningpoensis, 12 parts Platycodon grandiflorus, 12 parts Cyprinus thunbergii, 4 parts Lonicera japonica, 4 parts Bupleurum chinense, 4 parts Belamcanda chinensis, 4 parts Peucedanum praeruptorum, and 2.5 parts Trollius chinensis.

[0079] The difference from Example 1 is that no houttuynia cordata or artificial bezoar was added to the raw materials. In the preparation method, no houttuynia cordata was added in step (1) and no artificial bezoar was added in step (3), and the rest was the same as in Example 1.

[0080] Comparative Example 2

[0081] The raw materials of the traditional Chinese medicine composition, by weight, are: 15 parts of Houttuynia cordata, 16 parts of Astragalus membranaceus, 12 parts of Andrographis paniculata, 12 parts of Scrophularia ningpoensis, 12 parts of Platycodon grandiflorus, 12 parts of Cypripedium sarmentosum, 4 parts of Lonicera japonica, 4 parts of Belamcanda chinensis, 4 parts of Peucedanum praeruptorum, 2.5 parts of Trollius chinensis and 0.35 parts of artificial bezoar.

[0082] The difference from Example 1 is that Bupleurum was not added to the raw materials, but its dosage was added to Astragalus. In the preparation method, step (1) does not include Bupleurum, and the rest is the same as in Example 1.

[0083] Comparative Example 3

[0084] The raw materials of the traditional Chinese medicine composition, by weight, are: 15 parts of Houttuynia cordata, 12 parts of Andrographis paniculata, 12 parts of Scrophularia ningpoensis, 12 parts of Platycodon grandiflorus, 12 parts of Cypripedium truncatum, 4 parts of Lonicera japonica, 16 parts of Bupleurum chinense, 4 parts of Belamcanda chinensis, 4 parts of Peucedanum praeruptorum, 2.5 parts of Trollius chinensis and 0.35 parts of artificial bezoar.

[0085] The difference from Example 1 is that Astragalus membranaceus was not added to the raw materials, but its dosage was added to Bupleurum chinense. In the preparation method, step (1) does not include Astragalus membranaceus, and the rest is the same as in Example 1.

[0086] Comparative Example 4

[0087] The raw materials of the traditional Chinese medicine composition, by weight, are: 25 parts of Houttuynia cordata, 5 parts of Astragalus membranaceus, 17 parts of Andrographis paniculata, 5 parts of Scrophularia ningpoensis, 17 parts of Platycodon grandiflorus, 5 parts of Cypripedium sarmentosum, 1 part of Lonicera japonica, 8 parts of Bupleurum chinense, 1 part of Belamcanda chinensis, 7 parts of Peucedanum praeruptorum, 2.5 parts of Trollius chinensis and 0.35 parts of artificial bezoar.

[0088] The difference from Example 1 is that the proportions of certain ingredients in the prescription are different. The preparation method of the traditional Chinese medicine composition is the same as in Example 1.

[0089] Comparative Example 5

[0090] The raw materials of the traditional Chinese medicine composition, by weight, are: 15 parts of buckwheat, 12 parts of astragalus, 12 parts of andrographis paniculata, 12 parts of scrophularia ningpoensis, 12 parts of platycodon grandiflorus, 12 parts of monkey earring, 4 parts of honeysuckle, 4 parts of bupleurum chinense, 4 parts of belamcanda chinensis, 4 parts of angelica dahurica, 2.5 parts of golden lotus and 0.35 parts of artificial bezoar.

[0091] The difference from Example 1 is that Houttuynia cordata is replaced with an equal amount of buckwheat in the raw materials. In the preparation method, step (1) is replaced with buckwheat, and the rest is the same as in Example 1.

[0092] Test Example 1: In vitro antibacterial test

[0093] (1) Test samples: The traditional Chinese medicine compositions prepared in Examples 1-4 and Comparative Examples 1-5 were respectively prepared to 10 mg / mL and 100 mg / mL.

[0094] (2) Test bacteria: Streptococcus pyogenes, CICC10464; Isolation substrate: pharynx of children with epidemic pharyngitis. Activate the bacteria according to the bacterial strain instruction manual and set aside. Take the fresh culture of the above strain and dilute it with normal saline into a bacterial suspension of 1×10 Figure 1 cfu / m, and then dilute it with MHB into a bacterial suspension of 1×10 6 cfu / mL.

[0095] (3) Test method: The antibacterial activity was evaluated by the inhibition zone method: Drop 50 μL (1×10 6 cfu / mL) of the bacterial suspension onto the agar plate, and evenly spread it on the plate with a sterile spreader. Then place the drug-loaded susceptibility test paper with different concentrations (10 mg / mL and 100 mg / mL) on the agar plate, and then incubate it in an incubator at 37 °C for 24 h to observe the growth of bacteria. The experiment was independently repeated three times, and the average value was taken as the measurement result. The results are as Figure 1 shown.

[0096] (4) Test results: From the results of the inhibition zone diameter, it can be seen that compared with the control examples, the inhibition zone diameters of Examples 1-4 are significantly higher than those of Control Examples 1-5, proving that the traditional Chinese medicine composition of the present invention has an obvious in vitro inhibitory effect on Streptococcus pyogenes. Although Fagopyrum dibotrys with the same efficacy was used to replace Houttuynia cordata in Control Example 5, its antibacterial effect is higher than that of other control examples, but still lower than those of Examples 1-4; the results of Control Example 2 and Control Example 3 show that Bupleurum chinense and Astragalus membranaceus have a synergistic antibacterial effect on Streptococcus pyogenes. To sum up, the prescription raw materials and dosages of the present invention have a significant impact on the antibacterial activity of the final traditional Chinese medicine composition.

[0097] Test Example 2: In vivo test evaluation

[0098] 1. Acute pharyngitis model test

[0099] (1) Animals: SPF-grade SD rats, male, 6-8 weeks old, weighing 211.2-258.2 g, purchased from Guangdong Vital River Laboratory Animal Technology Co., Ltd. The experimental animal production license number is: SCXK(Yue)2022-0063, and the certificate number is: 44829700038486. After quarantine for 3 days, they were used after no abnormalities were found.

[0100] (2) Grouping: Take the male SD rats with qualified quarantine, randomly group them, with 8 rats in each group. The groups are normal control group, model control group, drug administration groups (positive control group, Examples 1-4 groups, Control Examples 1-5 groups).

[0101] ​​(3) Modeling and administration: Except for the normal control group, rats in other groups were sprayed with 15% ammonia water twice a day for 3 consecutive days to prepare an acute pharyngitis model.

[0102] After successful model establishment, all treatment groups were administered the drug via gavage. The date of the first administration was recorded as D1, the previous day as D0, and so on. Each group was administered the drug once a day for three consecutive days. The treatment groups were administered the corresponding drug via gavage at a dose of 10 mL / kg, while the normal control group and the model control group were administered physiological saline via gavage at a dose of 10 mL / kg.

[0103] The dosage calculation process for Examples 1-4 and Comparative Examples 1-5 is as follows: The human dosage of this traditional Chinese medicine composition is 73.71g of raw herbs per day. The adult weight is calculated as 60kg, and the rat weight as 200g. The dosage is converted according to the equivalent dosage for humans and animals (the formula for converting human and animal body surface area is: logS=0.8762+0.698logW, where S: body surface area, unit is cm). 2 W: body weight (in g), the equivalent dose for rats is 6.88 g crude drug / kg. Therefore, the designed dosage for rats in this experiment was 6.9 g crude drug / kg. Before the experiment, the traditional Chinese medicine compositions of Examples 1-4 and Comparative Examples 1-5 were dissolved in physiological saline according to the dosage and volume.

[0104] Positive control group: Compound Houttuynia cordata mixture (Zhejiang Guojing Pharmaceutical Co., Ltd., National Drug Approval Number Z20033124, 10mL×10 vials). The human clinical administration was calculated based on the maximum dose. The equivalent dose for rats was 8.4mL / kg. Therefore, the single dose for rats in the positive control group in this experiment was 8.4mL / kg.

[0105] (4) Detection method:

[0106] A: Gross visual observation and scoring of tissues: Gross visual observation and scoring of pharyngeal mucosa tissues were performed before modeling, before drug administration, and approximately 1 hour after drug administration on D2 and D3. The scoring criteria are shown in Table 1 below.

[0107] Table 1: Gross Visual Inspection Scoring of Tissue

[0108]

[0109] B: Histopathological examination: D3. After the gross examination and scoring of the tissues were completed, the rats were anesthetized and euthanized by exsanguination of the abdominal aorta (0.05 mL / animal) via intramuscular injection of Shutai-Sumianxin solution (10:1). The rats were then euthanized by exsanguination of the abdominal aorta. Pharyngeal tissue was collected, fixed in 10% formaldehyde solution, and then subjected to sampling, dehydration, embedding, sectioning, drying, and HE staining. The results of the stained sections are shown in the figure. Figure 2 Observe the pathological examination of the pharynx, score the pharyngeal tissue pathology, and calculate the total score. The scoring criteria are shown in Table 2 below.

[0110] Table 2: Histopathological Examination Scores

[0111]

[0112] (5) Data processing: Measurement data were summarized in Excel and expressed as mean ± standard deviation. SPSS 28.0 was used for analysis. One-way ANOVA was used for statistical analysis. When the variances were homogeneous, the LSD test was used for comparison between groups. When the variances were unequal, Dunnett's T3 test was used for comparison between groups. P < 0.05 was considered statistically significant.

[0113] (6) Test Results

[0114] A: The results of the tissue visual observation and scoring are shown in Table 3.

[0115] Table 3: Effects on gross pharyngeal score in rats with acute pharyngitis (x±SD)

[0116]

[0117] Note: vs. normal control group ## P<0.01; vs. model control group, *P<0.05; **P<0.01; vs. comparison with Example 1 group, between each treatment group & P<0.05, && P<0.01.

[0118] As shown in the table, after modeling (before drug administration), except for the normal control group, the gross pharyngeal score of all other groups was 3, indicating successful modeling. Compared with the normal control group, the gross pharyngeal scores of the model control group animals on days 2 and 3 were significantly higher than those of the normal control group (P<0.01). Compared with the model control group, the gross pharyngeal scores of the positive control group and groups 1-4 of Examples were significantly lower (P<0.01); groups 1-5 of Comparative Examples also reduced the gross pharyngeal scores to some extent (P<0.05), but there were certain differences compared with groups 1-4 of Examples. Among them, groups 1-4 of Comparative Examples showed significant differences compared with Example 1, and group 5 of Comparative Examples showed statistically significant differences compared with Example 1. The improvement of the signs of acute pharyngitis model animals by the prescription of this invention is comparable to that of the positive control compound Houttuynia cordata mixture, indicating that the prescription and preparation process of this invention have significant effects compared with the comparative examples.

[0119] B: The results of histopathological examination are shown in Table 4.

[0120] Table 4: Effects on pharyngeal pathological scores in rats with acute pharyngitis

[0121]

[0122] Note: vs normal control group, ##P < 0.01, #P < 0.05; vs model control group, **P < 0.01, *P < 0.05; vs Example 1 group, &P < 0.05 and &&P < 0.01 among each drug administration group.

[0123] As can be seen from the results in the table, compared with the normal control group, the epithelial damage of the pharyngeal tissue of the animals in the model control group, the inflammatory exudation in the cavity, the infiltration of inflammatory cells, the dilation and congestion of blood vessels, the tissue edema, and the total score of the pharyngeal tissue pathology score were all significantly increased (P < 0.01 or 0.05), indicating successful model establishment. Compared with the model control group, the epithelial damage of the pharyngeal tissue, the inflammatory exudation in the cavity, the infiltration of inflammatory cells, the dilation of blood vessels, the tissue edema, and the pharyngeal tissue pathology in each drug administration group were significantly improved.

[0124] In terms of the total pathology score, Examples 1-4 of the present invention and Comparative Examples 5-9 were significantly lower than the model control group. Moreover, Examples 1-4 had a better effect on improving acute pharyngitis pathology than the comparative examples in terms of statistical significance, and Examples 1-4 had a better improvement effect than the positive control group in terms of the total pathology score. From the difference in the effects between Comparative Example 1 and Example 1, it can be seen that Houttuynia cordata and artificial bezoar have an important impact on the efficacy of the medicine taste; from the difference in the effects between Comparative Examples 2-3 and Example 1, it can be seen that Astragalus membranaceus and Bupleurum chinense can achieve significant effects only by synergizing with other medicine tastes; from the difference in the effects between Comparative Example 4 and Example 1, it can be seen that the dosage of the prescription raw materials has a significant impact on the antibacterial activity of the final traditional Chinese medicine composition; although Comparative Example 5 uses Fagopyrum dibotrys with the same efficacy to replace Houttuynia cordata, both Fagopyrum dibotrys and Houttuynia cordata are heat-clearing drugs for clearing heat and detoxifying, not only their original plants look similar, but their effects and applications are also very similar. However, according to the experimental results, the effect of Comparative Example 5 is worse than that of Example 1, and the difference in their effects is statistically significant.

[0125] 2. Pyrogenic model test with dry yeast

[0126] (1) Animals: SPF-grade SD rats, male, 6-8 weeks old, weighing 196.9-236.2 g, purchased from Guangdong Vital River Laboratory Animal Technology Co., Ltd. The production license number of the experimental animals is: SCXK(Yue)2022-0063, and the certificate number is: 44829700039824. After 3 days of quarantine and no abnormalities were found, they were used.

[0127] (2) Grouping: Select the quarantined male SD rats and randomly divide them into groups of 8 each. The groups are normal control group, model control group, drug administration groups (positive control group, Example 1-4 groups, Comparative Example 1-5 groups).

[0128] (3) Modeling and Drug Administration: Except for the normal group, which was subcutaneously injected with physiological saline (10 mL / kg), the rats in the other groups were subcutaneously injected with 20% yeast-physiological saline suspension (10 mL / kg) on ​​their backs. Immediately after modeling, drugs were administered. Groups 1-4 and Comparative Examples 1-5 were administered a traditional Chinese medicine composition at a dose of 6.9 g crude drug / kg by gavage. The positive control group was administered a compound houttuynia cordata mixture at a dose of 8.4 mL / kg by gavage. The total administration volume was 10 mL / kg. The model control group and the normal control group were administered an equal volume (10 mL / kg) of physiological saline by gavage. Drug administration was performed twice a day, with an interval of approximately 4 hours.

[0129] (4) Detection method: Before modeling and 2h, 4h and 8h after the first administration of the drug, the anal temperature of the rats was measured and the increase in body temperature at each time point after drug administration was calculated: Increase in body temperature = body temperature at that time point - normal body temperature before modeling.

[0130] (5) Data processing: Measurement data were summarized in Excel and expressed as mean ± standard deviation. SPSS 28.0 was used for analysis. One-way ANOVA was used for statistical analysis. When the variances were homogeneous, the LSD test was used for comparison between groups. When the variances were unequal, Dunnett's T3 test was used for comparison between groups. P < 0.05 was considered statistically significant.

[0131] (6) Test Results

[0132] The specific results are shown in Table 5.

[0133] Table 5: Effects of yeast on body temperature in a pyrogenic rat model (x±SD, n=8)

[0134]

[0135] Note: vs normal control group, ##P<0.01, #P<0.05; vs model control group, **P<0.01, *P<0.05; vs Example 1 group, &P<0.05, &&P<0.01 among the drug administration groups.

[0136] As shown in Table 6, there was no statistically significant difference in body temperature among the groups before modeling (P>0.05). Two hours after drug administration, there was no statistically significant difference in the increase in body temperature among the groups except for the control group 4 (P>0.05). Compared with the normal control group, the body temperature of the animals in the model control group was significantly higher at 4 and 8 hours after drug administration (P<0.01), indicating that the fever model was successfully established.

[0137] Compared with the model control group, at 4 h and 8 h after administration, the increase in body temperature of animals in each administration group decreased to varying degrees. Specifically, at 4 h after administration, except for Comparative Example 4, the increase in body temperature in all other groups was significantly lower than that in the model control group, with statistically significant differences (P<0.05) or significant differences (P<0.01). At 8 h after administration, the increase in body temperature in the positive control group, Examples 1-4 groups, and Comparative Example 4 groups was significantly lower than that in the model control group, with statistically significant differences (P<0.05) or significant differences (P<0.01). Furthermore, at 4 h and 8 h after administration, the positive control and Examples 1-4 groups showed highly significant differences compared to the model control group (P<0.01). Therefore, for the effect of reducing body temperature in the fever model, Examples 1-4 groups were superior to Comparative Example 1-5 groups, indicating that the formulation and process of this invention have a significant impact on the body temperature-reducing effect of the traditional Chinese medicine composition.

[0138] In summary, all drug groups improved the gross and histopathological scores of the acute pharyngitis model animals and reduced the increase in body temperature from baseline in the yeast-induced fever model animals. Compared with the control group, the prescriptions in Examples 1-4 of this invention have a therapeutic effect on acute pharyngitis and an antipyretic effect. Their effects are superior to or equivalent to the compound Houttuynia cordata mixture in the positive control group, and they have good pharmaceutical properties and further development value.

[0139] 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 clearing heat and detoxifying, relieving sore throat and reducing swelling, characterized in that, The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 10-20 parts of Houttuynia cordata, 8-15 parts of Astragalus membranaceus, 8-15 parts of Andrographis paniculata, 8-15 parts of Scrophularia ningpoensis, 8-15 parts of Platycodon grandiflorus, 8-15 parts of Cypripedium lyratum, 2-6 parts of Lonicera japonica, 2-6 parts of Bupleurum chinense, 2-6 parts of Belamcanda chinensis, 2-6 parts of Peucedanum praeruptorum, 1-4 parts of Trollius chinensis, and 0.1-0.6 parts of artificial bezoar.

2. A method for preparing the traditional Chinese medicine composition according to claim 1, characterized in that, Includes the following steps: (1) Weigh out the following ingredients according to the weight proportions: Houttuynia cordata, Astragalus membranaceus, Andrographis paniculata, Scrophularia ningpoensis, Platycodon grandiflorus, Heliotropium indicum, Lonicera japonica, Bupleurum chinense, Belamcanda chinensis, Peucedanum praeruptorum, and Trollius chinensis. Add water and decoct. Filter and concentrate the filtrate under reduced pressure to obtain extract 1. (2) Add ethanol to extract 1 and stir evenly. After standing, filter and concentrate the filtrate under reduced pressure to obtain extract 2. (3) After vacuum drying of extract 2, pulverize it and add artificial bezoar to obtain the traditional Chinese medicine composition.

3. The preparation method according to claim 2, characterized in that, In step (1), the amount of water added for decoction is 6-10 times the total amount of raw materials, and the decoction is carried out 1-4 times, with each decoction lasting 1-4 hours.

4. The preparation method according to claim 2, characterized in that, In step (2), ethanol is added until the volume fraction of ethanol in the system is 50-95%, and the standing time is 2-8 hours.

5. The preparation method according to claim 2, characterized in that, The relative densities of extract 1 and extract 2 are selected from 1.10 to 1.

30.

6. A pharmaceutical preparation, characterized in that, The pharmaceutical preparation includes the traditional Chinese medicine composition according to claim 1 or the traditional Chinese medicine composition prepared by any one of the preparation methods according to claims 2-5.

7. The pharmaceutical preparation according to claim 6, characterized in that, The pharmaceutical preparation also includes one or more pharmaceutically acceptable excipients.

8. The pharmaceutical preparation according to any one of claims 6-7, characterized in that, The pharmaceutical preparation is an oral preparation, and the dosage form of the oral preparation is granules, decoction, tablets, capsules, powder, pills, oral liquid or syrup.

9. The use of the traditional Chinese medicine composition according to claim 1, or the traditional Chinese medicine composition obtained by the preparation method according to any one of claims 2-5, or the pharmaceutical preparation according to any one of claims 6-8, in the preparation of drugs for clearing heat and detoxifying, relieving sore throat and reducing swelling.

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