Traditional Chinese medicine composition for preventing and treating influenza and application thereof

Abstract

The invention discloses a traditional Chinese medicine composition for preventing and treating influenza and application of the traditional Chinese medicine composition, the traditional Chinese medicine'three-element 'formula theory of'relieving exterior syndrome, resolving dampness and strengthening body resistance' is adopted for scientific proportioning, and the traditional Chinese medicine composition is prepared from the following six medicinal materials: honeysuckle, pogostemon cablin, perilla leaf, ginseng, folium isatidis and rhizoma phragmitis which are matched according to a specific weight part range. The traditional Chinese medicine composition achieves the effects of combining cold and warm, and clearing and tonifying, and is suitable for various clinically common influenza syndromes to achieve synergistic prevention and treatment effects.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine, specifically relating to a traditional Chinese medicine composition for the prevention and treatment of influenza and its application. Background Technology

[0002] Acute respiratory infectious diseases are a category of diseases with high clinical incidence. Among them, the common cold and influenza pose a significant threat to public health due to their high incidence and wide spread, placing a heavy burden on individual health management and the social medical system. There is an urgent need for safe, efficient and universally applicable treatment solutions.

[0003] The common cold, as the most common acute respiratory infection, presents with symptoms such as nasal congestion, runny nose, headache, and sneezing, often accompanied by fever, chills, and cough. It not only affects patients' daily lives and work but can also be a common trigger for diseases such as asthma and pneumonia. If the condition is poorly controlled, it can lead to serious complications such as secondary bacterial infections, asthma exacerbations, and chronic obstructive pulmonary disease, further increasing the patient's health risks. In terms of the course of the illness, the severity of cold symptoms usually peaks 2-3 days after infection, and most patients recover naturally within 5-7 days. However, some symptoms (such as cough and fatigue) can persist for more than 3 weeks, prolonging the period of discomfort. Epidemiological survey data shows that the annual incidence of the common cold among community residents in my country is as high as 83.27%. Its high frequency and potential health hazards highlight the urgent need for effective treatments to rapidly improve clinical symptoms and reduce the risk of complications.

[0004] Influenza, another highly prevalent acute respiratory infectious disease, is caused by influenza viruses (mainly type A and type B). It is characterized by rapid transmission and widespread susceptibility, especially during the autumn and winter seasons when it tends to become epidemic. Compared to the common cold, influenza symptoms are more severe, typically presenting with sudden high fever, muscle aches, and fatigue. In severe cases, it can lead to fatal complications such as pneumonia, myocarditis, and respiratory failure, posing a particularly significant threat to high-risk groups such as the elderly, children, pregnant women, and patients with chronic diseases. Currently, clinical prevention and treatment methods for influenza mainly include two categories: chemical drugs and vaccines. However, both have significant limitations. Regarding chemical drugs, while neuraminidase inhibitors (such as oseltamivir) have a relatively rapid onset of action and can inhibit viral replication, they may cause gastrointestinal reactions such as nausea and vomiting during use. Furthermore, long-term use can easily lead to drug resistance in the virus. Additionally, there is insufficient safety data for use in special populations such as children and pregnant women, requiring strict limitations in clinical use. As for vaccine prevention, due to the ease with which influenza viruses undergo antigenic drift and antigenic conversion, it is difficult to maintain a consistently high match between vaccine strains and circulating strains. This results in problems such as insufficient timeliness and limited protection rates (usually between 40% and 60%). Moreover, vaccines are only suitable for prevention in healthy individuals and have no therapeutic effect on patients already infected with the influenza virus, failing to meet clinical treatment needs.

[0005] Influenza is classified as "seasonal cold" or "seasonal disease," belonging to the category of "epidemic diseases." Its etiology is mainly related to the irregular qi of the four seasons and the invasion of pathogenic factors. The *Huangdi Neijing* (Yellow Emperor's Inner Classic) is the earliest TCM work to discuss epidemic diseases, elaborating on their etiology and prevention principles. The *Suwen* (Plain Questions) chapter on acupuncture states, "When the five epidemics arrive, they are all contagious, regardless of age, and the symptoms are similar," reflecting the epidemic's characteristics of transmissibility and infectivity. It also summarizes the fundamental causes of the five epidemics as "insufficient human qi, weak weather, loss of human spirit, lack of concentration of divine light, and invasion of evil spirits." The *Huangdi Neijing* advocates a combined approach of strengthening the body's resistance and eliminating pathogenic factors in the prevention and treatment of epidemic diseases. As stated in the *Suwen*, "Those who are not infected have strong internal qi, and evil cannot invade. Avoid the poisonous qi, and the heavenly female will come." Modern TCM believes that influenza is often accompanied by a pathogenesis of "deficiency of the body's resistance and invasion of pathogenic factors," and treatment should consider the principle of "eliminating pathogenic factors without harming the body's resistance, and strengthening the body's resistance without retaining pathogenic factors." Against this backdrop, Traditional Chinese Medicine (TCM) is gradually demonstrating its unique value in influenza prevention and treatment due to its holistic advantages of multi-component and multi-target regulation. TCM treatment for influenza not only inhibits viral replication through multiple mechanisms but also regulates the body's immune function and enhances resistance. It effectively alleviates clinical symptoms such as fever, cough, fatigue, and muscle aches. More importantly, based on the theory of natural drug compatibility, TCM has a low overall incidence of side effects and high safety, making it suitable as a preventative medication and long-term treatment option. It is particularly suitable for vulnerable populations such as children, the elderly, and pregnant women, becoming an important alternative to existing influenza prevention and treatment methods.

[0006] However, current clinical applications of traditional Chinese medicine (TCM) still have many shortcomings and cannot fully meet clinical needs: First, traditional TCM decoctions require complex decoction processes, which are time-consuming and laborious, and inconvenient to carry and store, failing to meet the needs of modern fast-paced life and convenient clinical medication; Second, while traditional dosage forms such as pills and powders are convenient to take, their drug dissolution rate is slow and their onset of action is long, making it impossible to quickly relieve acute symptoms caused by influenza; Third, most commercially available TCM preparations are fixed-prescription formulations, and their ingredients and dosages cannot be adjusted. Influenza patients have different constitutions (such as qi deficiency, yin deficiency, phlegm-dampness, etc.), and TCM syndromes are complex and diverse (such as wind-cold, wind-heat, summer-dampness, etc.), making it difficult for fixed prescriptions to flexibly adapt to different individuals and syndromes, resulting in poor medication effects for some patients; Fourth, most existing TCM preparations are positioned as adjunctive therapy drugs, lacking strong targeting for the core symptoms of influenza (such as high fever and severe cough), making it difficult to use them independently as a first-line treatment option.

[0007] Chinese patent CN117159679A discloses a traditional Chinese medicine composition for treating influenza. This composition uses patchouli, a medicinal herb native to Lingnan, as its core ingredient, combined with perilla leaves, bupleurum, atractylodes, raw coix seed, ginger, angelica, and tangerine peel, among other raw materials (specific weight parts: patchouli 10-20 parts, perilla leaves 10-20 parts, bupleurum 15-30 parts, atractylodes 10-20 parts, raw coix seed 20-35 parts, ginger 10-20 parts, angelica 5-15 parts, tangerine peel). (5-15 doses), the formulation revolves around "relieving exterior symptoms and resolving dampness, strengthening the spleen and regulating qi": Patchouli is combined with Bupleurum and ginger to enhance the effects of relieving exterior symptoms and resolving dampness, and dispelling cold; Patchouli is combined with Perilla leaf, Atractylodes, raw Coix seed, and tangerine peel to achieve the effects of strengthening the spleen, regulating qi, and resolving dampness and harmonizing the stomach; Patchouli is combined with Angelica dahurica to enhance the effects of relieving exterior symptoms and opening the orifices, while the sweet, bland, and cool nature of raw Coix seed balances the pungent and warm herbs in the formula, avoiding excessive dampness and damage to yin, demonstrating a certain degree of ingenuity in formulation. However, the Chinese herbal composition disclosed in this patent still has significant limitations in clinical application and cannot fully meet the needs of influenza treatment: on the one hand, its applicability for syndrome differentiation is narrow, and the risk of misuse is high. The core principle of traditional Chinese medicine treatment of influenza is "syndrome differentiation and treatment," requiring the selection of appropriate prescriptions based on the patient's specific syndrome type (such as wind-cold, wind-heat, summer-dampness, heat-toxin accumulation, etc.). From the perspective of the composition, the principal herb, patchouli, is pungent and warm in nature. The assistant herbs, perilla leaf, ginger, atractylodes, angelica, and tangerine peel, are also mainly pungent and warm. Only raw coix seed (sweet, bland, and cool) balances the warm nature. The warm herbs in the overall formula dominate in terms of both quantity and weight. The formula is highly targeted at the syndrome of "external wind-cold-dampness" or "internal dampness combined with external wind-cold" (symptoms include severe chills, mild fever, heaviness in the head and body, muscle aches, abdominal distension, and white and greasy tongue coating). However, in clinical practice, influenza patients more commonly present with "wind-heat invading the defensive qi" (symptoms include high fever, mild chills, sore throat, thirst, red tongue with yellow coating) and "heat-toxin attacking the lungs" (symptoms include high fever, cough, wheezing, sticky or yellow phlegm, sore throat, red eyes, red tongue with yellow or greasy coating, and slippery and rapid pulse). If this pungent-warming combination is mistakenly used on such patients, it can easily lead to the problem of "treating heat with warmth," like adding fuel to the fire, causing the internal heat to intensify. This not only fails to alleviate symptoms but may also worsen fever, sore throat, thirst, and other discomforts, and even trigger adverse reactions such as exacerbating heat and damaging body fluids. This limitation not only greatly restricts the clinical applicability of this combination but also places extremely high demands on the diagnostic skills of clinicians, significantly increasing the risk of clinical misuse. On the other hand, this combination has insufficient antipyretic power and limited specificity for high fever symptoms. Sudden high fever (mostly above 39℃) is the core symptom of influenza (especially influenza A), and rapid and effective fever reduction is crucial for relieving patient suffering and preventing the condition from worsening.In this composition, the core drugs responsible for relieving exterior symptoms and reducing fever are Bupleurum (15-30 parts) and Perilla leaf (10-20 parts). Bupleurum excels at harmonizing and reducing fever, and clearing away the lesser yang, while Perilla leaf disperses wind-cold and has a milder effect in relieving exterior symptoms. Compared to classic powerful exterior-relieving formulas (such as Ephedra Decoction with Ephedra, and Major Blue Dragon Decoction with Ephedra + Gypsum), or powerful heat-clearing and detoxifying formulas (such as Qingwen Baidu Drink with Gypsum, Anemarrhena, Coptis, and Scutellaria), the formulation of this composition focuses more on "resolving dampness." Although it has its methods for relieving exterior symptoms and reducing fever, its power is not strong, and it lacks potent drug components and compatibility design specifically for high fever symptoms. For influenza patients with mild exterior cold symptoms but intense internal heat, or those who simply present with persistent high fever, this composition may result in a slow fever reduction and poor cooling effect due to insufficient exterior-relieving and heat-clearing power, requiring combination with physical cooling or other antipyretic drugs.

[0008] In summary, existing treatments for colds and influenza (chemical drugs, vaccines, and traditional Chinese medicine) all have their limitations. In particular, traditional Chinese medicine regimens are lacking in terms of syndrome differentiation suitability, targeting of core symptoms, and convenient dosage forms. Therefore, there is an urgent clinical need for a traditional Chinese medicine combination that has stronger syndrome differentiation applicability, better effect on core symptoms such as high fever, and more convenient dosage forms to effectively improve the treatment of influenza. Summary of the Invention

[0009] In order to overcome the above-mentioned shortcomings of the existing technology, the purpose of this invention is to provide a traditional Chinese medicine composition for the prevention and treatment of influenza and its application, which can be applied to various influenza syndromes, and is especially effective for patients with high fever symptoms.

[0010] The objective of this invention is achieved by at least one of the following technical solutions:

[0011] A traditional Chinese medicine composition for preventing and treating influenza, comprising the following raw materials in parts by weight:

[0012] Honeysuckle 3-9 parts

[0013] Patchouli 3-6 parts

[0014] 3-6 parts perilla leaves

[0015] 3-6 portions of ginseng

[0016] 3-6 parts of Daqingye (Isatis tinctoria leaves)

[0017] 3-9 parts of reed rhizome.

[0018] This traditional Chinese medicine composition has a proper balance of principal, assistant, adjuvant, and adjuvant herbs, combining cold and warm properties, clearing and tonifying, and complementing each other. It focuses on dispelling pathogenic factors and works together to relieve wind and heat, invigorate qi and support the body's resistance, so that "when the body's resistance is stored internally, pathogenic factors cannot invade."

[0019] Furthermore, the traditional Chinese medicine composition comprises the following raw materials in parts by weight:

[0020] 3-6 parts honeysuckle

[0021] Patchouli 3-6 parts

[0022] 3-6 parts perilla leaves

[0023] 3-5 portions of ginseng

[0024] 3-6 parts of Daqingye (Isatis tinctoria leaves)

[0025] 3-6 parts of reed rhizome.

[0026] Furthermore, in the aforementioned traditional Chinese medicine composition, the mass ratio of honeysuckle, perilla leaf, patchouli, indigo leaf, ginseng, and reed rhizome is 6:6:6:6:5:6 or 3:3:3:3:3:3.

[0027] More preferably, the traditional Chinese medicine composition comprises the following raw materials in parts by weight:

[0028] 6 portions of honeysuckle

[0029] Patchouli 6 parts

[0030] 6 portions of perilla leaves

[0031] 5 portions of ginseng

[0032] 6 portions of Daqingye (Isatis leaf)

[0033] Six parts of reed rhizome.

[0034] Furthermore, the traditional Chinese medicine composition is in the form of pills, tablets, capsules, granules, oral liquids, powders, injections, sprays, or teas.

[0035] Furthermore, the dosage form of the traditional Chinese medicine composition is a tea.

[0036] The use of any of the above-mentioned traditional Chinese medicine compositions in the preparation of medicines for the prevention and / or treatment of influenza.

[0037] Furthermore, the patient with the influenza has fever symptoms and one or more of the following symptoms: cough, sore throat, headache, muscle aches, and fatigue.

[0038] Furthermore, the fever symptom refers to a patient's body temperature ≥38℃.

[0039] More preferably, the patient's body temperature is an axillary temperature.

[0040] Furthermore, the syndrome of the patients with the influenza mentioned above is one of the following: external wind-cold-dampness, internal dampness and turbidity combined with external wind-cold, wind-heat attacking the defensive qi, or heat-toxin accumulation.

[0041] Furthermore, the patient with the influenza has a syndrome pattern of either wind-heat attacking the defensive qi or heat-toxin accumulation.

[0042] A traditional Chinese medicine tea composition for preventing and treating influenza, wherein the raw materials of the traditional Chinese medicine tea composition include the following components:

[0043] Honeysuckle 3-9 parts

[0044] Patchouli 3-6 parts

[0045] 3-6 parts perilla leaves

[0046] 3-6 portions of ginseng

[0047] 3-6 parts of Daqingye (Isatis tinctoria leaves)

[0048] 3-9 parts of reed rhizome;

[0049] The preparation method of the herbal tea composition is as follows:

[0050] (1) Weigh the raw materials according to the proportions;

[0051] (2) Soak the raw materials in boiling water for 10-30 minutes, and take the liquid to obtain the Chinese medicine composition tea.

[0052] Furthermore, the herbal tea composition comprises the following ingredients in parts by weight:

[0053] 3-6 parts honeysuckle

[0054] Patchouli 3-6 parts

[0055] 3-6 parts perilla leaves

[0056] 3-5 portions of ginseng

[0057] 3-6 parts of Daqingye (Isatis tinctoria leaves)

[0058] 3-6 parts of reed rhizome.

[0059] Furthermore, the herbal tea composition comprises the following ingredients in parts by weight:

[0060] 6 portions of honeysuckle

[0061] Patchouli 6 parts

[0062] 6 portions of perilla leaves

[0063] 5 portions of ginseng

[0064] 6 portions of Daqingye (Isatis leaf)

[0065] Six parts of reed rhizome.

[0066] Furthermore, the method of administration of the herbal composition tea is as follows: weigh the raw materials according to the ratio, and steep one dose in boiling water daily until it loses its flavor.

[0067] Furthermore, the course of treatment for the herbal tea composition is 5 days.

[0068] Furthermore, the patient with the influenza has fever symptoms and one or more of the following symptoms: cough, sore throat, headache, muscle aches, and fatigue.

[0069] Furthermore, the fever symptom refers to a patient's body temperature ≥38℃.

[0070] More preferably, the patient's body temperature is an axillary temperature.

[0071] Furthermore, the syndrome of the patients with the influenza mentioned above is one of the following: external wind-cold-dampness, internal dampness and turbidity combined with external wind-cold, wind-heat attacking the defensive qi, or heat-toxin accumulation.

[0072] Furthermore, the patient with the influenza has a syndrome pattern of either wind-heat attacking the defensive qi or heat-toxin accumulation.

[0073] Compared with the prior art, the present invention has the following advantages and beneficial effects:

[0074] (1) This invention adopts the "three elements" formula theory of traditional Chinese medicine, which is to relieve the exterior pathogen (honeysuckle / perilla leaf / indigo leaf) + resolve dampness and harmonize the middle (patchouli) + tonify qi and support the body (astragalus / ginseng). It breaks through the limitations of traditional pungent and warm or pure cold and cool formulas. It targets the pathogenesis of influenza "excessive pathogen and deficiency of the body with dampness", and achieves "eliminating pathogen without harming the body and supporting the body without retaining pathogen". The three modules of relieving the exterior, resolving dampness and supporting the body are scientifically matched. It uses six medicinal materials, namely honeysuckle, patchouli, perilla leaf, ginseng, indigo leaf and reed rhizome, and is matched according to a specific weight range to achieve the effect of using both cold and warm and clearing and tonifying. It is suitable for a variety of common influenza syndromes in clinical practice and breaks through the limitation of the single effect of existing tea drinks.

[0075] (2) The traditional Chinese medicine composition of the present invention can achieve prevention and treatment throughout the entire cycle, and is suitable for influenza prevention (for people with qi deficiency), acute phase treatment (fever / cough), and recovery conditioning. The traditional Chinese medicine composition includes ginseng, honeysuckle, and agastache, which can both relieve exterior symptoms and eliminate dampness, and also replenish qi, making it suitable for patients with various constitutions. Ginseng can replenish vital energy, and can boost the body's resistance to external pathogens and accelerate post-illness recovery, targeting symptoms of qi deficiency such as fatigue, shortness of breath, and lethargy during the course of influenza. Compared with antiviral drugs alone, this traditional Chinese medicine composition can shorten the course of the disease and reduce the risk of repeated influenza attacks and complications by simultaneously "clearing external pathogens" and "supporting vital energy", making it especially suitable for susceptible populations such as children, the elderly, and those with weak constitutions.

[0076] (3) The traditional Chinese medicine composition of the present invention has multi-target synergistic effect: it acts on viral replication, inflammatory response, immune regulation and other links at the same time.

[0077] (4) In a preferred embodiment of the present invention, the dosage form of the traditional Chinese medicine composition is a tea drink, which can be used in small amounts, multiple times, gently, and for a long time, unlike traditional decoctions or capsules. Detailed Implementation

[0078] The following examples further illustrate specific implementations of the present invention, but the implementation and protection of the present invention are not limited thereto. It should be noted that any processes not specifically described below are those that can be implemented or understood by those skilled in the art by referring to existing technology. Reagents or instruments whose manufacturers are not specified are considered to be conventional products that can be purchased commercially.

[0079] In this invention, the term "influenza" refers to an acute respiratory infectious disease caused by the influenza virus, which is often characterized by high fever, systemic poisoning symptoms (headache, limb and back pain, fatigue, loss of appetite), and other symptoms (runny nose, sore throat, dry cough, sometimes accompanied by eye pain and tearing). It is highly contagious and spreads rapidly, and is prone to causing epidemics or pandemics in the population.

[0080] In this invention, the term "tea drink" refers to a liquid dosage form made from Chinese medicinal materials (or their processed slices or coarse particles), which are simply processed (such as slicing or crushing) and then brewed or decocted with boiling water to be consumed as tea. It is a simplified form of the traditional Chinese medicine "decoction".

[0081] This invention provides a traditional Chinese medicine composition for preventing and treating influenza, comprising the following raw materials in parts by weight:

[0082] Honeysuckle 3-9 parts

[0083] Patchouli 3-6 parts

[0084] 3-6 parts perilla leaves

[0085] 3-6 portions of ginseng

[0086] 3-6 parts of Daqingye (Isatis tinctoria leaves)

[0087] 3-9 parts of reed rhizome.

[0088] This traditional Chinese medicine composition has a proper balance of principal, assistant, adjuvant, and adjuvant herbs, combining cold and warm properties, clearing and tonifying, and complementing each other. It focuses on dispelling pathogenic factors and works together to relieve wind and heat, invigorate qi and support the body's resistance, so that "when the body's resistance is stored internally, pathogenic factors cannot invade."

[0089] Honeysuckle is the dried flower bud or newly opened flower of *Lonicera japonica*, a plant in the Caprifoliaceae family. It is sweet and cold in nature, and enters the lung, heart, and stomach meridians. It has the functions of clearing heat and detoxifying, and dispersing wind-heat. It is used for the initial stage of febrile diseases, wind-heat syndrome, carbuncles and boils, dysentery due to heat toxins, and bloody stools.

[0090] Patchouli is the dried aerial part of the plant *Pogostemon cablin*, belonging to the Lamiaceae family. It is pungent and slightly warm in nature, and enters the spleen, stomach, and lung meridians. It is aromatic in nature, dispels turbidity, harmonizes the stomach and stops vomiting, and releases exterior pathogens to relieve summer heat. It is used for dampness obstructing the middle jiao, epigastric fullness and vomiting, summer-dampness syndrome, early stage of damp-heat syndrome, fever and fatigue, chest tightness, cold-dampness obstructing summer heat, abdominal pain, vomiting and diarrhea, nasal congestion and headache.

[0091] Perilla leaves are the dried leaves of the perilla plant (Perilla frutescens), belonging to the Lamiaceae family. They are pungent and warm in nature, and enter the lung and spleen meridians. They relieve exterior syndromes and dispel cold, regulate qi and harmonize the stomach. They are used for common cold due to wind-cold, cough and nausea, vomiting during pregnancy, and fish and crab poisoning.

[0092] Ginseng is the dried root and rhizome of the ginseng plant (Panax ginseng), belonging to the Araliaceae family. It is sweet, slightly bitter, and slightly warm in nature, and enters the spleen, lung, heart, and kidney meridians. It greatly replenishes vital energy, restores the pulse and consolidates the body's foundation, tonifies the spleen and lungs, generates fluids and nourishes blood, calms the mind and improves intelligence. It is used for weakness and impending collapse, cold limbs and weak pulse, poor appetite, lung deficiency with cough and asthma, thirst due to fluid depletion, internal heat and thirst, deficiency of qi and blood, chronic illness and emaciation, palpitations and insomnia, impotence and cold uterus.

[0093] Isatis leaf is the dried leaf of Isatis indigotica, a plant in the Brassicaceae family. It is bitter and cold in nature, and enters the Heart and Stomach meridians. It clears heat and detoxifies, cools the blood and eliminates rashes. It is used for febrile diseases with high fever, delirium, rashes, mumps, sore throat, erysipelas, and carbuncles.

[0094] Reed rhizome is the fresh or dried rhizome of the grass reed (Phragmites australis). It is sweet and cold in nature, and enters the lung and stomach meridians. It clears heat and drains fire, generates fluids and quenches thirst, relieves irritability, stops vomiting, and promotes urination. It is used for feverish thirst, cough due to lung heat, lung abscess with purulent sputum, vomiting due to stomach heat, and painful urination due to heat.

[0095] In some embodiments of the present invention, the traditional Chinese medicine composition comprises the following raw materials in parts by weight:

[0096] 3-6 parts honeysuckle

[0097] Patchouli 3-6 parts

[0098] 3-6 parts perilla leaves

[0099] 3-5 portions of ginseng

[0100] 3-6 parts of Daqingye (Isatis tinctoria leaves)

[0101] 3-6 parts of reed rhizome.

[0102] Preferably, in the traditional Chinese medicine composition of the present invention, the mass ratio of honeysuckle, perilla leaf, patchouli, indigo leaf, ginseng and reed rhizome is 6:6:6:6:5:6 or 3:3:3:3:3:3.

[0103] In one specific embodiment of the present invention, the traditional Chinese medicine composition comprises the following raw materials in parts by weight:

[0104] 6 portions of honeysuckle

[0105] Patchouli 6 parts

[0106] 6 portions of perilla leaves

[0107] 5 portions of ginseng

[0108] 6 portions of Daqingye (Isatis leaf)

[0109] Six parts of reed rhizome.

[0110] In some embodiments of the present invention, the traditional Chinese medicine composition is in the form of pills, tablets, capsules, granules, oral liquids, powders, injections, sprays, or tea. In some preferred embodiments of the present invention, the dosage form of the traditional Chinese medicine composition is tea. Traditional Chinese medicine tea substitutes are one of the special dosage forms of traditional Chinese medicine. The ingredients in traditional Chinese medicine tea substitutes are mostly neutral in nature, readily available, and consumed frequently in small doses. They are less irritating than decoctions and are suitable for long-term, sustained use. Traditional Chinese medicine tea substitutes are particularly effective in preventing respiratory diseases. Long-term practice has verified their contribution to protecting people's health. Due to their practicality, simplicity, and effectiveness, they are widely accepted and have become a derivative of Chinese tea culture.

[0111] The present invention also provides the use of the traditional Chinese medicine composition described in any of the above claims in the preparation of a medicament for the prevention and / or treatment of influenza.

[0112] In some embodiments of the present invention, the patient with influenza has fever symptoms and one or more of the following symptoms: cough, sore throat, headache, muscle aches, and fatigue. In some preferred embodiments of the present invention, the fever symptoms refer to a patient's body temperature ≥38°C. In one specific embodiment of the present invention, the patient's body temperature is an axillary temperature.

[0113] In some embodiments of the present invention, the syndrome of the patient with the influenza is one of the following: external wind-cold-dampness, internal dampness and turbidity combined with external wind-cold, wind-heat attacking the defensive qi, or heat-toxin attacking the lungs.

[0114] This invention also provides a traditional Chinese medicine composition tea for preventing and treating influenza, wherein the raw materials of the traditional Chinese medicine composition tea include the following components:

[0115] Honeysuckle 3-9 parts

[0116] Patchouli 3-6 parts

[0117] 3-6 parts perilla leaves

[0118] 3-6 portions of ginseng

[0119] 3-6 parts of Daqingye (Isatis tinctoria leaves)

[0120] 3-9 parts of reed rhizome;

[0121] The preparation method of the herbal tea composition is as follows:

[0122] (1) Weigh the raw materials according to the proportions;

[0123] (2) Soak the raw materials in boiling water for 10-30 minutes, and take the liquid to obtain the Chinese medicine composition tea.

[0124] In some embodiments of the present invention, the herbal tea composition is composed of the following raw materials in parts by weight:

[0125] 3-6 parts honeysuckle

[0126] Patchouli 3-6 parts

[0127] 3-6 parts perilla leaves

[0128] 3-5 portions of ginseng

[0129] 3-6 parts of Daqingye (Isatis tinctoria leaves)

[0130] 3-6 parts of reed rhizome.

[0131] Preferably, in the traditional Chinese medicine composition of the present invention, the mass ratio of honeysuckle, perilla leaf, patchouli, indigo leaf, ginseng and reed rhizome is 6:6:6:6:5:6 or 3:3:3:3:3:3.

[0132] In one specific embodiment of the present invention, the herbal tea composition is composed of the following raw materials in parts by weight:

[0133] 6 portions of honeysuckle

[0134] Patchouli 6 parts

[0135] 6 portions of perilla leaves

[0136] 5 portions of ginseng

[0137] 6 portions of Daqingye (Isatis leaf)

[0138] Six parts of reed rhizome.

[0139] In some embodiments of the present invention, the herbal composition tea is administered as follows: the raw materials are weighed according to the specified ratio, and one dose is steeped in boiling water daily until tasteless. In some preferred embodiments of the present invention, the course of treatment for the herbal composition tea is 5 days.

[0140] In some embodiments of the present invention, the patient with influenza has fever symptoms and one or more of the following symptoms: cough, sore throat, headache, muscle aches, and fatigue. In some preferred embodiments of the present invention, the fever symptoms refer to a patient's body temperature ≥38°C. In one specific embodiment of the present invention, the patient's body temperature is an axillary temperature.

[0141] Example 1: Animal Experiment

[0142] Drugs and reagents

[0143] Treatment group 1 medication formula: 6 parts honeysuckle, 6 parts perilla leaf, 6 parts patchouli, 6 parts indigo leaf, 5 parts ginseng, and 6 parts reed rhizome;

[0144] Treatment group 2 prescription: honeysuckle 3 parts, perilla leaf 3 parts, patchouli 3 parts, indigo leaf 3 parts, ginseng 3 parts, reed rhizome 3 parts;

[0145] The control group's first-line drug formula consisted of: 3 parts perilla leaf, 3 parts patchouli, 3 parts indigo leaf, 3 parts ginseng, 3 parts reed rhizome, and 3 parts licorice.

[0146] The second treatment formula for the control group consisted of: 3 parts honeysuckle, 3 parts perilla leaf, 3 parts patchouli, 3 parts indigo leaf, 5 parts reed rhizome, and 5 parts astragalus.

[0147] Mix all the herbs together, steep in boiling water for 10-30 minutes, and use the liquid as medicine.

[0148] Control group: physiological saline;

[0149] Model group: physiological saline.

[0150] Western medicine group: Oseltamivir

[0151] Influenza virus mouse-adapted strain PR8 (A / PuertoRico / 08); mouse IL-2 ELISA kit, mice reagent kit, mice All reagent kits were purchased from Shanghai Enzyme-Linked Biotechnology Co., Ltd.

[0152] Laboratory animals and grouping

[0153] Seventy 7-week-old SPF-grade female C57BL / 6J mice, weighing 17-20g, were purchased from Shanghai Bikeyi Biotechnology Co., Ltd.

[0154] Seventy mice were divided into four groups: model group, treatment group 1, treatment group 2, control group 1, control group 2, blank group, and western medicine group, with 10 mice in each group.

[0155] Main instruments

[0156] Heraleus-Fresco21 micro-refrigerated centrifuge (Thermo Fisher Scientific, Germany).

[0157] Modeling and drug administration

[0158] Except for 10 mice in the control group, the remaining 60 mice were intranasally inoculated with the mouse-adapted influenza virus strain PR8 (A / PuertoRico / 08). A light-dark cycle was maintained at 25℃ from 8:00 to 20:00. Mice were fed standard diets and had normal access to water. Symptoms were observed after 24 hours; the presence of shortness of breath, difficulty breathing, restlessness, and ruffled feathers indicated successful modeling. A total of 64 mice successfully developed the model: 9 in treatment group 1, 10 in treatment group 2, 9 in control group 1, 9 in control group 2, 8 in the drug group, 9 in the model group, and 10 in the control group. On the day the model was deemed successful, medication was administered via gavage. Mice in the drug group received 18 mg / kg of medication based on body weight. Treatment groups 1, 2, control groups 1, and 2 received 5 ml / kg of medication. The model group and the control group received the same volume of physiological saline via gavage for 14 consecutive days. After drug administration, blood was collected from the eyeballs, incubated overnight at 4°C, and then centrifuged at 3000 rpm for 10 min to collect serum. The procedure was performed according to the kit instructions. Serum serum levels were calculated. The concentrations were statistically processed using SPSS 25.0 software. Measurement data were analyzed using... This indicates that the t-test is used for those that conform to a normal distribution.

[0159] result

[0160] Compared with the control group mice, the serum of the model group mice had higher concentrations of... and The levels in both groups were significantly elevated; compared with the model group, the treatment group... The levels of TNF-α were significantly reduced (p < 0.01) and (p < 0.05) in the treatment group compared with the control group. The levels of TNF-α were significantly reduced (p < 0.05), as detailed in Table 1.

[0161] Table 1. Serum levels of TNF-α, IFN-γ, and IL-6 in each group of mice

[0162]

[0163] Note: * indicates p < 0.01 compared to the control group; # indicates p < 0.01 or p < 0.05 compared to the model group; & indicates p < 0.05 compared to control group 1. △ This indicates that compared with control group 1, p<0.05.

[0164] This invention adds an animal experiment step to verify the safety and mechanism of action of the traditional Chinese medicine composition, providing a basis for clinical research.

[0165] Example 2 Clinical Trial

[0166] 1. Materials and Methods

[0167] 1.1 Clinical Data

[0168] This study included 273 influenza patients admitted to Shuguang Hospital between November 1, 2024 and March 30, 2025; the patients were divided into a treatment group (n=182) and a control group (n=91).

[0169] 1.2 Inclusion Criteria

[0170] Western medicine diagnostic criteria: formulated with reference to the latest definition in the "Influenza Diagnosis and Treatment Protocol (2020 Edition)".

[0171] Traditional Chinese medicine (TCM) syndrome differentiation is based on the "Guiding Principles for Clinical Research of New Chinese Herbal Drugs," the "Clinical Practice Guidelines for the Treatment of Influenza with Traditional Chinese Medicine (2021)," and the "Standards for Diagnosis and Efficacy Evaluation of Diseases and Syndromes in Traditional Chinese Medicine." Clinical manifestations of the syndrome of pathogenic factors invading the lung and wei levels include:

[0172] Main symptoms: fever, cough, sore throat, headache, muscle aches, and fatigue;

[0173] Secondary symptoms: chills, sweating, thirst, nasal congestion, runny nose;

[0174] Tongue and pulse: The tongue is red with a thin or thin greasy coating, and the pulse is floating and rapid.

[0175] The presence of fever and any other primary symptom, combined with secondary symptoms, tongue appearance, and pulse, can clarify the TCM syndrome type.

[0176] Patients meeting the above diagnostic criteria for influenza (lung-invading type) must meet the following criteria: ① age 18-65 years, regardless of gender; ② body temperature ≥38℃, and have experienced one or more respiratory symptoms (cough, nasal congestion, runny nose, sore throat) and one or more systemic symptoms (fatigue, headache, myalgia) within 36 hours prior to enrollment; have the above-mentioned influenza clinical manifestations and have one or more of the following positive etiological test results: ① positive influenza virus nucleic acid test, ② positive influenza antigen test, ③ positive influenza virus culture and isolation, ④ influenza virus-specific IgG antibody levels in paired serum samples from the acute and convalescent phases; be willing to accept treatment and be able to take oral medication; and sign an informed consent form.

[0177] 1.3 Exclusion Criteria

[0178] ① Patients who received an influenza vaccine within 12 months prior to the start of the study; ② Patients exhibiting severe influenza symptoms such as difficulty breathing and requiring oxygen; ③ Patients with critical illnesses such as respiratory failure, acute necrotizing encephalopathy, septic shock, or multiple organ dysfunction; ④ Patients with immunodeficiency diseases such as HIV / AIDS who are currently receiving systemic steroids or other immunosuppressants; ⑤ Patients taking traditional Chinese medicine or antiviral drugs with similar efficacy to the investigational drug; ⑥ Pregnant or lactating women; ⑦ Patients diagnosed with COVID-19; ⑧ Patients who do not meet the inclusion criteria, have not taken medication as prescribed, whose efficacy cannot be determined, or whose data is incomplete, thus affecting the assessment of efficacy or safety; ⑨ Patients who were participating in other clinical trials within one month prior to enrollment.

[0179] Randomized controlled design and strict inclusion / exclusion criteria, compared to simply applying procedures, add complex operations such as grouping and standardized diagnosis, ensuring the scientific validity and reproducibility of experimental results.

[0180] 1.4 Experimental Design

[0181] (1) Design type: randomized controlled trial design

[0182] (2) Randomization: Random numbers were generated using SPSS 25.0 software and made into random assignment cards, which were then sealed in envelopes with the same serial number as the cards. When eligible patients entered the experiment, they were given treatment according to the order of their entry, opening the envelopes with the same serial number and being assigned to the groups specified on the cards inside the envelopes. Eligible subjects were divided into the treatment group and the control group in a 1:1 ratio.

[0183] 1.5 Intervention Measures

[0184] Symptomatic treatment: Follow the recommended treatment plan in the "Influenza Diagnosis and Treatment Protocol (2020 Edition)". Apply ice packs for physical cooling when the patient's temperature is between 38.0 and 38.5°C; administer acetaminophen orally for fever reduction when the temperature is above 38.5°C. If evidence of bacterial or other pathogenic infection is found during treatment, appropriate antibiotics may be selected based on the causative pathogen or empirically. Record the name, dosage, route of administration, duration of treatment, and reason for use of any concurrent medications on the medical record form.

[0185] Treatment group: Honeysuckle 6g, Perilla leaf 6g, Patchouli 6g, Isatis leaf 6g, Ginseng 5g, Reed rhizome 6g;

[0186] Control group: Perilla leaf 3g, patchouli 3g, Isatis leaf 3g, ginseng 3g, reed rhizome 3g, licorice 3g.

[0187] Mix all the herbs together, steep in boiling water for 10-30 minutes, and drink as tea. Take one dose daily, steeping multiple times until it loses its flavor. The course of treatment is 5 days.

[0188] 1.6 Observation Indicators

[0189] Key outcome measure: time to fever reduction

[0190] 2. Results

[0191] For patients whose primary symptom was fever, with symptoms including fever for 1 day, body temperature greater than 38°C, accompanied by nasal congestion, runny nose, headache, fatigue, and sore throat, each patient was treated with a traditional Chinese medicine herbal tea. The treatment group consisted of 182 patients, and the control group consisted of 91 patients. The symptom distribution and age distribution of patients in each group were the same, with no statistical difference. Fever reduction was defined as the axillary temperature dropping below 37°C and remaining below 37°C for 24 hours. The results are shown in Table 2.

[0192] Table 2 Comparison of fever reduction time between the two groups (hours)

[0193]

[0194] 3. Conclusion

[0195] After one course of treatment (5 days), the average fever reduction time in the control group was 53.29±16.12 (h), while the average fever reduction time in the experimental group was 39.18±12.51 (h), which was shorter than that in the control group (p<0.05).

[0196] The above embodiments are merely preferred embodiments of the present invention and are only used to explain the present invention, not to limit the present invention. Any changes, substitutions, modifications, etc., made by those skilled in the art without departing from the spirit and essence of the present invention should be within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for preventing and treating influenza, characterized in that, It consists of the following raw materials in parts by weight: Honeysuckle 3-9 parts Patchouli 3-6 parts 3-6 parts perilla leaves 3-6 portions of ginseng 3-6 parts of Daqingye (Isatis tinctoria leaves) 3-9 parts of reed rhizome.

2. The traditional Chinese medicine composition for preventing and treating influenza according to claim 1, characterized in that, The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 3-6 parts honeysuckle Patchouli 3-6 parts 3-6 parts perilla leaves 3-5 portions of ginseng 3-6 parts of Daqingye (Isatis tinctoria leaves) 3-6 parts of reed rhizome.

3. The traditional Chinese medicine composition for preventing and treating influenza according to claim 2, characterized in that, In the aforementioned traditional Chinese medicine composition, the mass ratio of honeysuckle, perilla leaf, patchouli, indigo leaf, ginseng, and reed rhizome is 6:6:6:6:5:6 or 3:3:3:3:3:

3.

4. The traditional Chinese medicine composition for preventing and treating influenza according to claim 3, characterized in that, The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 6 portions of honeysuckle Patchouli 6 parts 6 portions of perilla leaves 5 portions of ginseng 6 portions of Daqingye (Isatis leaf) Six parts of reed rhizome.

5. The traditional Chinese medicine composition for preventing and treating influenza according to claim 1, characterized in that, The traditional Chinese medicine composition is in the form of pills, tablets, capsules, granules, oral liquids, powders, injections, sprays, or teas.

6. The traditional Chinese medicine composition for preventing and treating influenza according to claim 5, characterized in that, The dosage form of the traditional Chinese medicine composition is a tea.

7. The use of the traditional Chinese medicine composition according to any one of claims 1-6 in the preparation of a medicament for the prevention and / or treatment of influenza.

8. The application according to claim 7, characterized in that, The patient with the influenza has fever and one or more of the following symptoms: cough, sore throat, headache, muscle aches or fatigue.

9. The application according to claim 7, characterized in that, The patients with the aforementioned influenza were diagnosed with one of the following syndromes: external wind-cold-dampness, internal dampness combined with external wind-cold, wind-heat attacking the defensive qi, or excessive heat-toxin.

10. A traditional Chinese medicine composition tea for preventing and treating influenza, characterized in that, The raw materials for the herbal tea composition include the following components: Honeysuckle 3-9 parts Patchouli 3-6 parts 3-6 parts perilla leaves 3-6 portions of ginseng 3-6 parts of Daqingye (Isatis tinctoria leaves) 3-9 parts of reed rhizome; The preparation method of the herbal tea composition is as follows: (1) Weigh the raw materials according to the proportions; (2) Soak the raw materials in boiling water for 10-30 minutes, and take the liquid to obtain the Chinese medicine composition tea.

Images