Traditional Chinese medicine composition for clearing away heat and toxic materials and relieving sore-throat and swelling as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition for clearing away heat and toxic materials and relieving sore throat and swelling and a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicine. 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 radix scrophulariae, 8-15 parts of platycodon grandiflorum, 8-15 parts of pithecellobium clypearia, 2-6 parts of honeysuckle, 2-6 parts of radix bupleuri, 2-6 parts of blackberry lily, 2-6 parts of radix peucedani, 1-4 parts of trollflower and 0.1-0.6 part of calculus bovis factitius. The traditional Chinese medicine composition disclosed by the invention has the effects of clearing away heat and toxic materials, relieving sore throat and diminishing swelling, and relieving cough and reducing sputum, and is mainly used for treating wind-heat type common cold, fever caused by wind-heat affecting lung and excessive lung heat, viscous nasal discharge or yellow nasal discharge, swollen sore throat, cough and expectoration, yellow and thick phlegm, head and body pain, red tongue and yellow fur and the like; the traditional Chinese medicine composition can be used for treating influenza, acute upper respiratory infection, acute pharyngitis, amygdalitis and the like with the syndromes. And the effect is better than that of each contrast.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for clearing away heat and detoxifying, relieving sore throat and reducing swelling, as well as a preparation method and use thereof. Background Art

[0002] Pharyngitis is a nonspecific inflammation of the pharynx, a general term for inflammation caused by various microbial infections. It can occur alone, coexist with rhinitis, tonsillitis, and laryngitis, or serve as a prodromal symptom for certain diseases. It can be categorized as acute or chronic. Acute pharyngitis is an acute inflammation of the pharyngeal mucosa and submucosal tissues, often involving the pharyngeal lymphoid tissue. The inflammation may be localized in the early stages but may progress to involve the entire pharyngeal cavity, being more common in autumn and winter, and during the transition between winter and spring. Key symptoms include dryness, burning, pain, dysphagia, and pharyngeal congestion and swelling. Chronic pharyngitis can be further categorized as chronic simple pharyngitis, chronic hypertrophic pharyngitis, and atrophic pharyngitis. Chronic simple pharyngitis is more common, with lesions primarily located in the mucosal layer, manifesting as chronic congestion of the pharyngeal mucosa, hyperplasia of the mucosal and submucosal connective tissue, and hypertrophy of the mucous glands, resulting in increased mucus secretion. Patients often cough up sticky phlegm from their throats, or experience a foreign body sensation in their throats that they are unable to cough up or swallow. Causes of pharyngitis include: invasion of external pathogens, such as wind-cold and wind-heat, which invade the pharynx; dietary restrictions, such as excessive consumption of spicy, greasy, and irritating foods, or excessive alcohol consumption; emotional imbalance, such as depression and anxiety; and organ dysfunction, such as malfunction of the lungs, spleen, and kidneys.

[0003] Western medicine primarily treats both acute and chronic pharyngitis with antibacterial, antiviral, and glucocorticoid medications, such as cephalosporins, penicillins, and roxithromycin. While initial symptoms may improve, pharyngeal symptoms return to their original state over time. Drug resistance can develop, making the condition difficult to cure and associated with multiple adverse reactions. Furthermore, antibiotics are ineffective in treating sore throats caused by viral infections and can lead to environmental antibiotic pollution.

[0004] Traditional Chinese medicine (TCM) treatments for pharyngitis primarily rely on the principle of syndrome differentiation and treatment, using appropriate Chinese herbal formulas. Currently, Chinese patent medicines such as Lanqin Oral Liquid, Pudilan Anti-inflammatory Oral Liquid, and Compound Houttuynia Cordata Mixture are recommended as common treatments for acute pharyngitis. TCM treatments demonstrate unique advantages in addressing acute conditions, particularly influenza and fevers. Using TCM to treat illnesses has positive implications for replacing antibiotics and curbing drug resistance. Common TCM formulas for pharyngitis include: Yangyin Qingfei Decoction, composed of Rehmannia root, Ophiopogon japonicus, and Scrophularia ningpoensis, which nourishes yin and clears the lungs. Zhibai Dihuang Wan, containing Anemarrhena asphodeloides, Phellodendron chinense, and Rehmannia glutinosa, nourishes yin and reduces internal heat. Sangju Yin, containing mulberry leaves and chrysanthemums, dispels wind, clears heat, and relieves sore throats. Yinqiao Powder, composed of honeysuckle and forsythia, clears heat and detoxifies. Huanglian Shangqing Wan, whose main ingredient is Coptis chinensis, clears heat and reduces internal heat. Traditional Chinese medicine has minimal toxicity and side effects in treating acute and chronic pharyngitis. It often achieves good results in relieving the symptoms of chronic pharyngitis and reducing the recurrence rate, treating both the symptoms and the root cause, such as:

[0005] Chinese invention patent application CN118743742A discloses a traditional Chinese medicine composition for treating chronic pharyngitis. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 15-25 parts of ophiopogon japonicus, 10-20 parts of yam, 10-20 parts of American ginseng, 20-30 parts of Scrophularia ningpoensis, 5-15 parts of gypsum, 8-12 parts of anemarrhena, 20-30 parts of reed rhizome, 15-25 parts of honeysuckle, etc. The preparation method and use of the traditional Chinese medicine composition are also disclosed. The invention achieves the purpose of treating chronic pharyngitis by nourishing the lungs and kidneys, clearing the lungs and relieving heat, soothing the liver, regulating qi and resolving phlegm, promoting fluid production and moistening 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 traditional Chinese medicine composition is made from the following raw materials, measured by mass: 1-18 parts of Astilbe chinensis, 1-12 parts of Tripterygium wilfordii, 1-30 parts of Solidago asiatica, 1-30 parts of Forsythia suspensa, 1-24 parts of Asparagus cochinchinensis, 1-21 parts of Radix Ophiopogonis, 1-30 parts of Scrophularia ningpoensis, 1-30 parts of Chrysanthemum indicum, 1-30 parts of Radix Rehmanniae, 1-20 parts of Platycodon grandiflorum, and 1-20 parts of Radix Glycyrrhizae. Astilbe chinensis, Tripterygium wilfordii, and Solidago asiatica are monarch drugs; Scrophularia ningpoensis, Forsythia suspensa, and Chrysanthemum indicum are ministerial drugs; Radix Rehmanniae, Radix Ophiopogonis, and Asparagus cochinchinensis are adjuvant drugs; and Platycodon grandiflorum and Glycyrrhiza uralensis are guiding drugs. The traditional Chinese medicine composition is suitable for acute pharyngitis, chronic pharyngitis, and tonsillitis, and has the effects of clearing away heat and toxic substances, nourishing yin and reducing internal heat, dispersing stagnation and relieving swelling, and clearing the throat.

[0007] Common classifications found in Traditional Chinese Medicine texts include spleen deficiency, spleen and kidney yang deficiency, phlegm coagulation and blood stasis, and lung and kidney yin deficiency, but these are far from covering the complex and varied clinical pathogenesis. Existing pharyngitis prescriptions often use single therapies, such as Banxia Houpu Decoction to relieve depression, promote qi circulation, and resolve phlegm; Kujiu Decoction to dispel pathogenic factors, resolve stagnation, and reduce swelling; Platycodon Decoction to clear heat, detoxify, and relieve sore throat; or Liuwei Dihuang Wan to nourish yin, tonify the kidney, and relieve sore throat. Overall, however, current treatments for pharyngitis are suboptimal. Summary of the Invention

[0008] In order to solve the problems in the prior art that the body is easily tolerant to Western medicine treatment of pharyngitis, the ingredients of Chinese medicine compositions are complex and the treatment method is single, the present invention provides a Chinese medicine composition for clearing away heat and detoxifying, relieving sore throat and swelling, as well as its preparation method and use. Through the mutual compatibility and synergistic effect of the drugs, the therapeutic effect is significantly improved, achieving the effect of treating both the symptoms and the root cause.

[0009] In order to achieve the above object, the technical solution adopted by the present invention is as follows:

[0010] The invention provides a traditional Chinese medicine composition for clearing away heat and detoxifying, relieving sore throat and relieving swelling. 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, 8-15 parts of andrographis paniculata, 8-15 parts of figwort, 8-15 parts of platycodon, 8-15 parts of monkey earrings, 2-6 parts of honeysuckle, 2-6 parts of bupleurum, 2-6 parts of belamcanda, 2-6 parts of peucedanum peucedanum, 1-4 parts of trollius and 0.1-0.6 parts of artificial bezoar.

[0011] Preferably, the raw materials are calculated by weight as follows: 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 grandiflorum, 10-14 parts of Monkey Ear Rings, 2-6 parts of Honeysuckle, 2-6 parts of Bupleurum chinense, 2-6 parts of Belamcanda chinensis, 2-6 parts of Peucedanum peucedanum, 1-4 parts of Nasturtium and 0.2-0.4 parts of artificial bezoar.

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

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

[0014] (1) Weigh houttuynia cordata, astragalus root, andrographis paniculata, Scrophularia ningpoensis, Platycodon grandiflorum, monkey earring, honeysuckle, bupleurum root, belamcanda root, peucedanum chinense, and trollius chinensis according to weight, add water and decoct, filter, and concentrate the filtrate under reduced pressure to obtain extract 1;

[0015] (2) Adding extract 1 to ethanol and stirring evenly, letting it stand and then filtering, the filtrate was concentrated under reduced pressure to obtain extract 2;

[0016] (3) The extract 2 is vacuum-dried and then crushed, and artificial bezoar is added to obtain a traditional Chinese medicine composition.

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

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

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

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

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

[0022] Furthermore, the pharmaceutical preparation further comprises one or more pharmaceutically acceptable adjuvants 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 a use of the above-mentioned traditional Chinese medicine composition or the traditional Chinese medicine composition prepared by the above-mentioned preparation method or the above-mentioned pharmaceutical preparation in preparing medicines for clearing away heat and detoxifying, relieving sore throat and reducing swelling.

[0026] Furthermore, the indications of the drug include wind-heat cold, runny or yellow nasal discharge, sore throat, cough and sputum, thick yellow sputum, headache and body pain, red tongue with yellow fur, as well as influenza, upper respiratory tract infection, pharyngitis, tonsillitis, etc.

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

[0028] Houttuynia cordata: Properties and flavors: Pungent; Cold; Liver and Lung meridians; Indications: Clears heat and detoxifies, promotes diuresis and reduces swelling. Treats pneumonia, lung abscesses, febrile dysentery, malaria, edema, gonorrhea, leucorrhea, carbuncle, hemorrhoids, rectal prolapse, eczema, alopecia, and scabies. "Southern Yunnan Materia Medica": Treats lung abscess, cough with pus and blood, fishy-smelling sputum, large intestine heat and toxins, and hemorrhoids.

[0029] Astragalus: Bitter and cold in nature; enters the Lung, Gallbladder, Spleen, Large Intestine, and Small Intestine meridians. Indications: Purging excessive internal heat, dispelling damp-heat, stopping bleeding, and stabilizing pregnancy. Treats high fever, thirst, lung-heat cough, damp-heat diarrhea, jaundice, stranguria due to heat, vomiting, epistaxis, metrorrhagia, bleeding, conjunctivitis, swelling, and pain in the eyes, restless fetuses, carbuncles, and furuncles. "Bielu": Treats phlegm-heat, stomach heat, lower abdominal cramps, aids digestion, promotes small bowel movement, treats blood retention in women, stranguria, and abdominal pain in children.

[0030] Andrographis paniculata: Bitter and cold in nature; enters the Heart, Lung, Large Intestine, and Bladder meridians. It clears heat and detoxifies, cools blood and reduces swelling. It is used for colds and fevers, sore throats, mouth sores, sudden coughs, diarrhea, dysentery, painful stranguria caused by heat, carbuncles, ulcers, and snake and insect bites.

[0031] Scrophularia: sweet, bitter, salty in taste, slightly cold in nature; enters the spleen, stomach, and kidney meridians; has the effects of clearing heat and cooling blood, nourishing yin and reducing fire, detoxifying and dispersing stagnation; used for febrile diseases with heat entering the blood, fever, thirst, red tongue, rashes, bone steaming and fatigue cough, restlessness and insomnia, loss of body fluid and constipation, blurred vision, sore throat, scrofula, phlegm nodules, carbuncles and ulcers.

[0032] Platycodon grandiflorum: Nature and flavor: bitter; pungent; neutral; enters the Lung and Stomach meridians. Indications: Promotes lung qi, eliminates phlegm and pus. Treats exogenous cough, sore throat, lung abscess with pus vomiting, chest fullness and flank pain, dysentery and abdominal pain. "Bielu": Benefits the five internal organs and the stomach, replenishes blood and qi, eliminates cold and heat, rheumatism, warms the middle and helps digestion, and treats sore throat and pharynx.

[0033] Monkey earrings were first mentioned in Li Shizhen's Compendium of Materia Medica during the Ming Dynasty and also in Zhao Xuemin's Luchuan Materia Medica during the Qing Dynasty. The dried leaves, stems, and branches of the monkey earring are used as medicine. They have a slightly bitter and astringent taste and are slightly cold in nature. They enter the spleen, stomach, and liver meridians, and have the effects of clearing heat and detoxifying, cooling blood and reducing swelling, stopping diarrhea, and removing dampness and healing sores.

[0034] Honeysuckle: Also known as honeysuckle, it is sweet and cold in nature. It belongs to the lung, heart, and stomach meridians and has anti-inflammatory, detoxifying, throat-clearing and sore throat benefits. It is often used to treat carbuncles, sores, wind-heat colds, dampness-induced fevers, and other ailments.

[0035] Bupleurum: The dried root of Bupleurum chinense or Bupleurum angustifolia, both of the Apiaceae family. It has a pungent, bitter, and slightly cold flavor. It harmonizes the exterior and interior, soothes the liver and relieves depression, elevates yang and lifts deficient qi, reduces fever, and stops malaria. It is used for colds, fever, alternating chills and fever, chest and flank pain, irregular menstruation, uterine prolapse, and rectal prolapse.

[0036] Belamcanda: Bitter in nature and flavor; cold; bitter. Enters the Lung and Liver meridians. Clears heat and detoxifies; dispels phlegm and relieves sore throat; dissipates blood stasis and resolves stagnation. Treats sore throat; cough, asthma; scrofula, tuberculosis; malaria; leukorrhea; carbuncles, swellings, and sores.

[0037] Peucedanum chinense: Bitter and pungent in flavor, slightly cold in nature. It enters the Lung meridian. It has the effects of descending Qi, resolving phlegm, dispersing wind and clearing heat. It is used for symptoms such as wheezing due to phlegm-heat, coughing up thick yellow phlegm, and wind-heat cough with excessive phlegm.

[0038] Nasturtium: bitter in taste and cold in nature; has the effect of clearing away heat and detoxifying; used for upper respiratory tract infections, tonsillitis, pharyngitis, acute otitis media and other diseases; its main active ingredients are flavonoids and phenolic acids; has antioxidant, antibacterial, antiviral, anti-inflammatory, anti-tumor, antipyretic and analgesic pharmacological effects.

[0039] Artificial Bezoar: According to Traditional Chinese Medicine, bezoar has a delicate aroma, a slightly bitter taste followed by sweetness, and a cooling nature. It enters the Heart and Liver meridians. It can be used to reduce fever, detoxify, and calm nerves. It can be taken internally to treat high fever, coma, epilepsy, infantile convulsions, and seizures. It can also be used externally to treat sore throats, mouth sores, carbuncles, and toxic conditions. Artificial bezoar is made from a mixture of ox bile powder, bile acid, hyodeoxycholic acid, taurine, bilirubin, cholesterol, and trace elements. Its composition is known.

[0040] Golden buckwheat: Slightly pungent and astringent, with a cooling nature, it enters the Lung meridian. It clears heat and detoxifies, eliminates carbuncles and discharges pus, resolves phlegm and relieves sore throats, and strengthens the spleen and aids 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 sore throat properties are beneficial for lung-heat coughs and sore throats. Its spleen-strengthening and digestion-promoting properties are beneficial for abdominal distension, loss of appetite, and weight loss caused by malnutrition.

[0041] Golden buckwheat and Houttuynia cordata are both heat-clearing and detoxifying medicines. Not only do their original plants look similar, their effects and applications are also very similar.

[0042] Compared with the prior art, the present invention has the following beneficial effects:

[0043] (1) The Chinese medicine composition prepared by the present invention has the effects of clearing away heat and detoxifying, relieving sore throat and swelling, relieving cough and reducing phlegm, and is mainly used to treat wind-heat cold, which is caused by wind-heat invading the lungs, fever, runny nose or yellow mucus, sore throat, cough and expectoration, thick yellow phlegm, headache and body pain, red tongue with yellow fur, etc., as well as influenza, acute upper respiratory tract infection, acute pharyngitis, tonsillitis and other patients with the above symptoms. The prescription is not only unique in conception and has no obvious toxic and side effects, but also has significant efficacy, achieving the effect of treating both the symptoms and the root cause, helping to shorten the patient's treatment cycle and reduce the recurrence rate.

[0044] (2) The present invention provides a traditional Chinese medicine composition for clearing away heat and detoxifying, relieving sore throat and reducing swelling. After scientific compatibility, the synergistic cooperation between the effective ingredients is extracted, which helps to give full play to the therapeutic effect of the traditional Chinese medicine composition, while ensuring the efficacy of the medicine and also improving the utilization rate of the medicine.

[0045] (3) The present invention replaces Houttuynia cordata with Golden Fagopyrum, which has the same heat-clearing and detoxifying effect, indicating that the raw materials and mass fractions of the present invention have a significant effect on the efficacy. In addition, the direct synergistic effect of the raw materials, especially Astragalus and Bupleurum, is demonstrated. The results of in vivo animal tests show that it can significantly improve the effects of pharyngitis and fever, and can effectively solve the problem of single or unsatisfactory therapeutic effects of existing traditional Chinese medicines. BRIEF DESCRIPTION OF THE DRAWINGS

[0046] Figure 1 The antibacterial test results of the traditional Chinese medicine composition of Test Example 1 are as follows;

[0047] Figure 2 These are the HE-stained sections of the pharyngeal tissue pathology of the rats in each group of Experimental Example 2, wherein A is the blank control group (the pharyngeal epithelium is intact, and no inflammatory cell infiltration is seen under the epithelium; HE×100), B is the model control group (the pharyngeal epithelium is necrotic, with inflammatory exudate in the cavity, vasodilation under the epithelium, inflammatory cell infiltration, tissue hemorrhage and edema; HE×100), C is the positive control group of the compound houttuynia mixture (inflammatory cell infiltration, vasodilation and congestion under the pharyngeal epithelium; HE×100), and D is the Chinese medicine composition group of Example 1 (inflammatory cell infiltration under the epithelium of the pharyngeal tissue; HE×100). DETAILED DESCRIPTION

[0048] The present invention is illustrated below by way of examples to facilitate understanding and grasp of the technical solutions of the present invention, but the present invention is not limited thereto. The experimental methods described in the following examples are conventional methods unless otherwise specified; the medicinal materials and reagents described are commercially available unless otherwise specified; and the performance of products from different sources does not significantly affect each other.

[0049] When numerical ranges are given in the examples, it should be understood that, unless otherwise specified herein, 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 herein have the same meaning as commonly understood by those of ordinary skill in the art to which the invention belongs.

[0050] Unless otherwise specified, the various chemical reagents and raw materials used in the examples of the present invention were obtained through conventional commercial channels, and products from different manufacturers have no significant effect on the effects.

[0051] Example 1

[0052] The raw materials of the traditional Chinese medicine composition are as follows by weight: 15 parts of houttuynia cordata, 12 parts of astragalus, 12 parts of andrographis paniculata, 12 parts of scrophulariae, 12 parts of platycodon, 12 parts of monkey earrings, 4 parts of honeysuckle, 4 parts of bupleurum, 4 parts of belamcanda, 4 parts of peucedanum, 2.5 parts of trollius and 0.35 parts of artificial bezoar.

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

[0054] (1) Weigh the raw materials Houttuynia cordata, Astragalus membranaceus, Andrographis paniculata, Scrophularia ningpoensis, Platycodon grandiflorum, Monkey Ear Ring, Honeysuckle Flos, Bupleurum Root, Belamcanda Root, Peucedanum chinense, and Nasturtium in parts by weight, add 6 times the total weight of the above raw materials into water, decoct once, decoct for 4 hours, filter the decoction to obtain a filtrate, and concentrate under reduced pressure to obtain an extract 1 with a relative density of 1.10;

[0055] (2) Adding ethanol to extract 1, stirring until the alcohol content reaches 60% at the end point, letting it stand for 2 hours, filtering to obtain the filtrate, and concentrating under reduced pressure to obtain extract 2 with a relative density of 1.30;

[0056] (3) The extract 2 is vacuum-dried and then crushed, and artificial bezoar is added to obtain a traditional Chinese medicine composition.

[0057] Example 2

[0058] The raw materials of the traditional Chinese medicine composition are as follows by weight: 10 parts of houttuynia cordata, 8 parts of astragalus, 8 parts of andrographis paniculata, 8 parts of scrophulariae, 8 parts of platycodon, 8 parts of monkey earrings, 2 parts of honeysuckle, 2 parts of bupleurum, 2 parts of belamcanda, 2 parts of peucedanum, 1 part of trollius and 0.1 part of artificial bezoar.

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

[0060] (1) Weigh the raw materials Houttuynia cordata, Astragalus membranaceus, Andrographis paniculata, Scrophularia ningpoensis, Platycodon grandiflorum, Monkey Ear Ring, Honeysuckle Flos, Bupleurum Root, Belamcanda Root, Peucedanum chinense, and Nasturtium in proportion to their weight, add 8 times the total weight of the above raw materials into water and boil, repeatedly boil the filtered Chinese medicinal residues with water, filter, combine the obtained filtrates, boil for 2 h each time, and concentrate the filtrates under reduced pressure to obtain an extract 1 with a relative density of 1.20;

[0061] (2) Adding ethanol to extract 1, stirring until the alcohol content reaches 80% at the end point, letting it stand for 4 hours, filtering to obtain the filtrate, and concentrating under reduced pressure to obtain extract 2 with a relative density of 1.30;

[0062] (3) The extract 2 is vacuum-dried and then crushed, and artificial bezoar is added to obtain a traditional Chinese medicine composition.

[0063] Example 3

[0064] The raw materials of the traditional Chinese medicine composition are as follows by weight: 20 parts of houttuynia cordata, 15 parts of astragalus, 15 parts of andrographis paniculata, 15 parts of scrophulariae, 15 parts of platycodon, 15 parts of monkey earrings, 6 parts of honeysuckle, 6 parts of bupleurum, 6 parts of belamcanda, 6 parts of peucedanum, 4 parts of trollius and 0.6 parts of artificial bezoar.

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

[0066] (1) Weigh the raw materials Houttuynia cordata, Astragalus membranaceus, Andrographis paniculata, Scrophularia ningpoensis, Platycodon grandiflorum, Monkey Ear Ring, Honeysuckle Flos, Bupleurum Root, Belamcanda Root, Peucedanum chinense, and Nasturtium in proportion to their weight, add 10 times the total weight of the above raw materials into water and decoct, repeatedly add water to the filtered Chinese medicinal residues, filter, combine the obtained filtrates, decoct for a total of 4 times, each decoction for 1 hour, and concentrate the filtrate under reduced pressure to obtain an extract 1 with a relative density of 1.10;

[0067] (2) Adding ethanol to extract 1, stirring until the alcohol content reaches 95% at the end point, letting it stand for 8 hours, filtering to obtain the filtrate, and concentrating under reduced pressure to obtain extract 2 with a relative density of 1.30;

[0068] (3) The extract 2 is vacuum-dried and then crushed, and artificial bezoar is added to obtain a traditional Chinese medicine composition.

[0069] Example 4

[0070] The raw materials of the traditional Chinese medicine composition are as follows by weight: 15 parts of houttuynia cordata, 8 parts of astragalus, 15 parts of andrographis paniculata, 8 parts of scrophulariae, 15 parts of platycodon, 8 parts of monkey earrings, 6 parts of honeysuckle, 2 parts of bupleurum, 6 parts of belamcanda, 2 parts of peucedanum, 3 parts of trollius and 0.2 parts of artificial bezoar.

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

[0072] (1) Weigh the raw materials Houttuynia cordata, Astragalus membranaceus, Andrographis paniculata, Scrophularia ningpoensis, Platycodon grandiflorum, Monkey Ear Ring, Honeysuckle Flos, Bupleurum Root, Belamcanda Root, Peucedanum chinense, and Nasturtium in proportion to their weight, add 8 times the total weight of the above raw materials into water and decoct, repeatedly add water to the filtered Chinese medicinal residues, filter, combine the obtained filtrates, decoct twice, each time for 3 hours, and concentrate the combined filtrates under reduced pressure to obtain an extract 1 with a relative density of 1.10;

[0073] (2) Adding ethanol to extract 1, stirring until the alcohol content reaches 50% at the end point, letting it stand for 5 hours, filtering to obtain the filtrate, and concentrating under reduced pressure to obtain extract 2 with a relative density of 1.30;

[0074] (3) The extract 2 is vacuum-dried and then crushed, and artificial bezoar is added to obtain a traditional Chinese medicine composition.

[0075] Example 5

[0076] Preparation of granules: Take the traditional Chinese medicine composition prepared in Example 1, grind it into fine powder, add appropriate amount of powdered sugar and dextrin and 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 are as follows by weight: 12 parts of astragalus, 12 parts of andrographis, 12 parts of Scrophularia, 12 parts of Platycodon, 12 parts of monkey ear ring, 4 parts of honeysuckle, 4 parts of bupleurum, 4 parts of beam dry, 4 parts of peucedanum and 2.5 parts of trollius.

[0079] The difference from Example 1 is that houttuynia cordata and artificial bezoar are not added to the raw materials. In the preparation method, houttuynia cordata is not added in step (1), and artificial bezoar is not added in step (3). The rest is the same as in Example 1.

[0080] Comparative Example 2

[0081] The raw materials of the traditional Chinese medicine composition are as follows by weight: 15 parts of houttuynia cordata, 16 parts of astragalus, 12 parts of andrographis paniculata, 12 parts of scrophulariae, 12 parts of platycodon, 12 parts of monkey earrings, 4 parts of honeysuckle, 4 parts of belamcanda, 4 parts of peucedanum, 2.5 parts of trollius and 0.35 parts of artificial bezoar.

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

[0083] Comparative Example 3

[0084] The raw materials of the traditional Chinese medicine composition are as follows by weight: 15 parts of houttuynia cordata, 12 parts of andrographis paniculata, 12 parts of Scrophularia ningpoensis, 12 parts of Platycodon grandiflorum, 12 parts of monkey earrings, 4 parts of honeysuckle, 16 parts of bupleurum, 4 parts of beam dryness, 4 parts of peucedanum, 2.5 parts of trollius and 0.35 parts of artificial bezoar.

[0085] The difference from Example 1 is that no Astragalus is added to the raw materials, and its amount is added to that of Bupleurum. In the preparation method, Astragalus is not added in step (1), and the rest is the same as in Example 1.

[0086] Comparative Example 4

[0087] The raw materials of the traditional Chinese medicine composition are as follows by weight: 25 parts of houttuynia cordata, 5 parts of astragalus, 17 parts of andrographis paniculata, 5 parts of scrophulariae, 17 parts of platycodon, 5 parts of monkey earrings, 1 part of honeysuckle, 8 parts of bupleurum, 1 part of belamcanda, 7 parts of peucedanum, 2.5 parts of trollius and 0.35 parts of artificial bezoar.

[0088] The difference from Example 1 is that the quantities of some raw materials in the prescription are different. The preparation method of the Chinese medicine composition is the same as that of Example 1.

[0089] Comparative Example 5

[0090] The raw materials of the traditional Chinese medicine composition are as follows: 15 parts of golden buckwheat, 12 parts of astragalus, 12 parts of andrographis, 12 parts of Scrophularia, 12 parts of Platycodon, 12 parts of monkey earrings, 4 parts of honeysuckle, 4 parts of bupleurum, 4 parts of beam dryness, 4 parts of peucedanum, 2.5 parts of trollius and 0.35 parts of artificial bezoar.

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

[0092] Test Example 1: In vitro antibacterial test

[0093] (1) Test sample: the Chinese medicine compositions prepared in Examples 1-4 and Comparative Examples 1-5, prepared at 10 mg / mL and 100 mg / mL, respectively.

[0094] (2) Test bacteria: Streptococcus pyogenes, CICC10464; Isolation medium: pharynx of children with epidemic pharyngitis. Activate the strain according to the strain instructions and set aside. Take the fresh culture of the above strain and dilute it with physiological saline to 1×10 8 cfu / m bacterial suspension, and then diluted with MHB to 1×10 6 cfu / mL of bacterial suspension.

[0095] (3) Test method: The antibacterial activity was evaluated by the inhibition zone method: 50 μL (1×10 6 cfu / mL) bacterial suspension was dropped onto the agar plate and evenly spread on the plate with a sterile applicator. Then, drug-sensitive paper sheets with different concentrations (10 mg / mL and 100 mg / mL) were placed on the agar plate and then incubated in a 37°C incubator for 24 hours to observe bacterial growth. The experiment was repeated three times independently and the average value was taken as the measurement result. The results are shown in the figure below. Figure 1 shown.

[0096] (4) Test results: Figure 1 The results of the inhibition zone diameters show that, compared to the comparative examples, the inhibition zone diameters of Examples 1-4 were significantly higher than those of Comparative Examples 1-5, demonstrating that the Chinese herbal composition of the present invention has a significant in vitro inhibitory effect against Streptococcus pyogenes. Although Comparative Example 5 uses Fagopyrum serrata (Fagopyrum truncatum) with the same efficacy in place of Houttuynia cordata, its antibacterial effect, while higher than that of the other comparative examples, is still lower than that of Examples 1-4. The results of Comparative Examples 2 and 3 demonstrate that Bupleurum chinense and Astragalus membranaceus have a synergistic antibacterial effect against Streptococcus pyogenes. In summary, the formulation ingredients and dosage of the present invention have a significant impact on the antibacterial activity of the final Chinese herbal composition.

[0097] Test Example 2: In vivo 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 Weitonglihua Experimental Animal Technology Co., Ltd., with the experimental animal production license number: SCXK (Yue) 2022-0063, and the qualification certificate number: 44829700038486. They were quarantined for 3 days and used after no abnormalities were found.

[0100] (2) Grouping: Male SD rats that passed the quarantine were randomly divided into groups of 8 rats each, namely normal control group, model control group, and drug-treated groups (positive control group, Example 1-4 groups, and Comparative Example 1-5 groups).

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

[0102] After successful model establishment, each treatment group received the drug by gavage. The first day of administration was designated D1, the day before as D0, and so on. Each group was dosed once daily for three consecutive days. The treatment groups received the corresponding drug at a dose volume of 10 mL / kg, while the normal control and model control groups received normal saline at a dose of 10 mL / kg.

[0103] The specific calculation process of the dosage of Example 1-4 and Comparative Example 1-5 groups is as follows: the daily dosage of the Chinese medicine composition for human use is 73.71 g of the raw medicine, the adult weight is 60 kg, the rat weight is 200 g, and the equivalent dose of human and animal is converted (the conversion formula of human and animal body surface area is: logS=0.8762+0.698logW, S: body surface area, unit is cm 2 (W: body weight, in g). The rat equivalent dose is 6.88 g crude drug / kg. Therefore, the rat dosage in this experiment was designed to be 6.9 g crude drug / kg. Before the experiment, the Chinese medicine compositions of Example 1-4 and Comparative Example 1-5 were dissolved in normal saline according to the dosage and administration volume.

[0104] Positive control group: Compound Houttuynia Cordata mixture (Zhejiang Guojing Pharmaceutical Co., Ltd., national medicine standard Z20033124, 10 mL × 10 bottles). The human clinical administration is calculated according to the maximum dose, and the equivalent dose for rats is 8.4 mL / kg. Therefore, the single administration dose for rats in the positive control group in this experiment is 8.4 mL / kg.

[0105] (4) Detection method:

[0106] A: Macroscopic observation and scoring of tissues: Before modeling, before drug administration, and about 1 hour after drug administration on D2 and D3, the pharyngeal mucosal tissues were observed and scored with macroscopic observation. The scoring criteria are shown in Table 1.

[0107] Table 1: Tissue macroscopic observation scores

[0108]

[0109] B: Histopathological examination: D3, after the tissues were observed and scored with the naked eye, the animals were intramuscularly injected with a solution of Shutai-Suminxin (10:1) (0.05 mL / animal). After anesthesia, the animals were bled from the abdominal aorta. The rat pharyngeal tissues were obtained and fixed with 10% formaldehyde solution. The tissues were collected, dehydrated, embedded, sliced, and dried for HE staining. The results of the stained sections are shown in the figure. Figure 2 The pharyngeal tissue was observed and pathologically scored, and the total score was calculated. The scoring criteria are shown in Table 2 below.

[0110] Table 2: Histopathological examination scores

[0111]

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

[0113] (6) Test results

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

[0115] Table 3: Effects on the macroscopic score of the pharynx in rats with acute pharyngitis model (x±SD)

[0116]

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

[0118] As shown in the table, after modeling (before administration), except the normal control group, all the other groups of animal pharynx naked eye scores were all 3, indicating that modeling was successful. Compared with the normal control group, the model control group animal D2, D3 pharynx naked eye scores were significantly higher than the normal control group (P < 0.01). Compared with the model control group, the positive control group and embodiment 1-4 group animal pharynx naked eye scores all reduced, with extremely significant difference (P < 0.01); Comparative Example 1-5 group also can reduce naked eye score (P < 0.05) to a certain extent, but there is certain difference with embodiment 1-4 group, wherein comparative example 1-4 group is significantly different compared with embodiment 1, and comparative example 5 group is statistically significant compared with embodiment 1. The improvement of acute pharyngitis model animal signs by prescription of the present invention is suitable with the effect of positive control compound herba houttuyniae mixture, illustrating that prescription of the present invention and preparation technology are compared with comparative example and have significant effect.

[0119] B: Histopathological examination results are shown in Table 4.

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

[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, &&P<0.01 among each drug-treated group.

[0123] As shown in the table, compared with the normal control group, the model control group showed significant increases in pharyngeal epithelial damage, intraluminal inflammatory exudate, inflammatory cell infiltration, vascular dilation and congestion, tissue edema, and the total score of pharyngeal tissue pathology (P < 0.01 or 0.05), indicating successful model establishment. Compared with the model control group, all drug-treated groups showed significant improvements in pharyngeal epithelial damage, intraluminal inflammatory exudate, inflammatory cell infiltration, vascular dilation, tissue edema, and pharyngeal tissue pathology.

[0124] In terms of the total pathological score, Examples 1-4 and Comparative Examples 5-9 of the present invention all have a significant reduction relative to the model control group, and Examples 1-4 have a better acute pharyngitis pathological improvement effect than the comparative example in a statistically significant manner, and Examples 1-4 have a better improvement effect in terms of the total pathological score than the positive control group. From the difference in the effect of Comparative Example 1 and Example 1, it can be seen that Houttuynia cordata and artificial bezoar have an important influence on the efficacy of the medicinal flavor; and from the difference in the effect of Comparative Examples 2-3 and Example 1, it can be seen that Astragalus and Bupleurum chinense can achieve a significant effect in conjunction with other medicinal flavors; from the difference in the effect of Comparative Example 4 and Example 1, it can be seen that the amount of the prescription raw materials has a significant effect on the antibacterial activity of the final Chinese medicine composition; although Comparative Example 5 uses Golden Buckwheat with the same efficacy to replace Houttuynia cordata, Golden Buckwheat and Houttuynia cordata are both heat-clearing and detoxifying drugs. Not only do the original plants look similar, their efficacy and application are also very similar, but according to the experimental results, it can be seen that the effect of Comparative Example 5 is worse than that of Example 1, and the difference in effect between the two is statistically significant.

[0125] 2. Dry yeast pyrogenicity model test

[0126] (1) Animals: SPF grade SD rats, male, 6-8 weeks old, weighing 196.9-236.2 g, purchased from Guangdong Weitonglihua Experimental Animal Technology Co., Ltd., with the experimental animal production license number: SCXK (Yue) 2022-0063, and the qualification certificate number: 44829700039824. They were quarantined for 3 days and used after no abnormalities were found.

[0127] (2) Grouping: Male SD rats that passed the quarantine were randomly divided into groups of 8 rats each, namely normal control group, model control group, and drug-treated groups (positive control group, Example 1-4 groups, and Comparative Example 1-5 groups).

[0128] (3) Modeling and Administration: Except for the normal group, which received a subcutaneous injection of physiological saline (10 mL / kg), all other groups received a subcutaneous injection of 20% yeast-physiological saline suspension (10 mL / kg) on ​​the back. Immediately after modeling, the rats in Example 1-4 and Comparative Example 1-5 groups were gavaged with a Chinese herbal composition at a dose of 6.9 g of crude drug / kg. The positive control group was gavaged with 8.4 mL / kg of compound houttuynia cordata mixture, with a dosage of 10 mL / kg. The model control group and the normal control group were gavaged with an equal volume of physiological saline (10 mL / kg). The drugs were administered twice a day, approximately 4 hours apart.

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

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

[0131] (6) Test results

[0132] See Table 5 for specific results.

[0133] Table 5: Effects on body temperature in dry yeast-induced fever model rats (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 each drug-treated group.

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

[0137] Compared with the model control group, after administration 4h, 8h, the increase in the body temperature of each administration group animal all has various degrees of reduction, wherein, after administration 4h, except comparative example 4 groups, the body temperature increase in all the other groups is all obviously lower than the model control group, and the difference has statistical significance (P < 0.05) or significant difference (P < 0.01); After administration 8h, the body temperature increase in the positive control group, embodiment 1-4 group, comparative example 4 groups is all obviously lower than the model control group, and the difference has statistical significance (P < 0.05) or significant difference (P < 0.01). Meanwhile, after administration 4h and 8h, the positive control and embodiment 1-4 groups have extremely significant differences (P < 0.01) relative to the model control group. Therefore, for the pyrogenic model body temperature reducing effect, the effect of embodiment 1-4 group is better than comparative example 1-5 group, shows that prescription of the present invention and technique have the influence of significance for the hypothermia effect of Chinese medicine composition.

[0138] Based on the above results, all drug groups improved the macroscopic and histopathological scores of the acute pharyngitis model animals and reduced the increase in body temperature compared to the baseline in the dry yeast-induced fever model animals. Compared to the comparative example, the prescriptions of Examples 1-4 of the present invention showed therapeutic effects on acute pharyngitis and had antipyretic effects, with effects superior to or equivalent to the compound houttuynia mixture of the positive control group, demonstrating good drugability and worthy of further development.

[0139] Finally, it should be noted that the above content is only used to illustrate the technical solution of the present invention, rather than to limit the scope of protection of the present invention. Simple modifications or equivalent substitutions of the technical solution of the present invention by ordinary technicians in this field do not deviate from the essence and scope of the technical solution of the present invention.

Claims

1. A Chinese medicine composition for clearing away 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, 8-15 parts of andrographis paniculata, 8-15 parts of figwort, 8-15 parts of platycodon, 8-15 parts of monkey earrings, 2-6 parts of honeysuckle, 2-6 parts of bupleurum, 2-6 parts of belamcanda, 2-6 parts of peucedanum, 1-4 parts of truncatum and 0.1-0.6 parts of artificial bezoar.

2. A Chinese medicine composition according to claim 1, characterized in that: The weight ratio of astragalus to bupleurum is 8-15:2-6.

3. A method for preparing the Chinese medicine composition according to any one of claims 1-2, characterized in that: The following steps are involved: (1) Weigh houttuynia cordata, astragalus, andrographis paniculata, scrophularia, platycodon, monkey earrings, honeysuckle, bupleurum, belamcanda, peucedanum peucedanum, and truncatum according to weight proportions, add water and decoct, filter, and concentrate the filtrate under reduced pressure to obtain extract 1; (2) Adding extract 1 to ethanol and stirring evenly, letting it stand and then filtering, and concentrating the filtrate under reduced pressure to obtain extract 2; (3) The extract 2 is vacuum dried and then crushed, and artificial bezoar is added to obtain a traditional Chinese medicine composition.

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

5. The preparation method according to claim 3, 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.

6. The preparation method according to claim 3, characterized in that: The relative density of extract 1 and extract 2 is independently selected from 1.10-1.

30.

7. A pharmaceutical preparation, characterized in that The pharmaceutical preparation comprises the traditional Chinese medicine composition according to any one of claims 1 to 2 or the traditional Chinese medicine composition prepared by the preparation method according to any one of claims 3 to 6.

8. The pharmaceutical preparation according to claim 7, characterized in that The pharmaceutical preparation may further comprise one or more pharmaceutically acceptable adjuvants and / or excipients.

9. The pharmaceutical preparation according to any one of claims 7-8, characterized in that The pharmaceutical preparation is an oral preparation, and the dosage form of the pharmaceutical preparation includes granules, decoctions, tablets, capsules, powders, pills, oral liquids or syrups.

10. Use of the Chinese medicine composition according to any one of claims 1 to 2, or the Chinese medicine composition obtained by the preparation method according to any one of claims 3 to 6, or the pharmaceutical preparation according to any one of claims 7 to 9 in the preparation of medicines for clearing away heat and detoxifying, relieving sore throat and reducing swelling.

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