Traditional Chinese medicine composition and preparation for treating exogenous fever of children and preparation method of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition for treating children exogenous fever, a preparation and a preparation method of the traditional Chinese medicine composition. The traditional Chinese medicine composition is prepared from 10-120 parts of radix isatidis, 5-50 parts of fructus forsythiae, 5-50 parts of radix puerariae, 5-50 parts of radix scutellariae, 5-50 parts of cortex lycii radicis, 5-50 parts of radix gentianae macrophyllae, 10-120 parts of gypsum, 5-50 parts of herba artemisiae annuae, 5-50 parts of radix bupleuri, 5-50 parts of fructus gardeniae and 5-50 parts of radix glycyrrhizae. The composition can be prepared into a traditional Chinese medicine preparation for oral administration, the preparation method is improved on the basis of traditional decoction, the steps are simple, the medicine is non-toxic and few in adverse reaction, after the medicine is taken, fever can be abated in a short time, the curative effect is good, the effect taking speed is high, and popularization and popularization are facilitated.

Description

Technical Field

[0001] The present application belongs to the technical field of traditional Chinese medicine, and specifically relates to a traditional Chinese medicine composition, a preparation and a preparation method thereof for treating exogenous fever in children. Background Art

[0002] Fever refers to the body temperature rising beyond the normal range when the body is under the action of pyrogens or various reasons cause dysfunction of the body temperature regulation center, that is, the body temperature rises beyond the upper limit of normal body temperature fluctuations in a day. In clinical work, rectal temperature ≥38℃ or axillary temperature ≥37.5℃ is usually defined as fever. Abnormal body temperature should be regarded as a manifestation of disease. Fever is the most common symptom in children and the most common complaint in pediatric outpatient clinics, especially in emergency departments. The causes of fever can be divided into infectious fever and non-infectious fever. Infectious fever can be seen in viral infection, bacterial infection, parasitic infection, fungal infection, atypical microbial infection, etc. according to the different pathogens of infection, among which viral and bacterial infections are the most common. In recent years, infections with atypical microorganisms such as Mycoplasma pneumoniae and various fungal infections are also very common. Infections with certain special bacteria, such as tuberculosis and non-tuberculous mycobacterial disease, brucellosis, etc., also occur from time to time. Common non-infectious fever causes include rheumatic and autoimmune diseases, tumors and tumor diseases, diseases involving the hypothalamic temperature center, heat production and heat dissipation disorders, and others such as trauma, surgery, drug fever, adverse reactions to vaccination, dehydration fever, heat stroke, diabetes insipidus, etc.

[0003] Current research suggests that fever is usually caused by the action of fever activators on the body, which activate the body's endogenous pyrogen cells (including monocytes, macrophages, endothelial cells, lymphocytes, stellate cells and tumor cells, etc.), causing them to produce and release endogenous pyrogens (EP), including interleukin-1, tumor necrosis factor, interferon, interleukin-6, macrophage inflammatory protein-1, etc. EP can be transported into the brain through the blood-brain barrier or act on the body temperature regulation center through the terminal plate vascular organ, causing the body temperature to rise. Among them, fever activators are divided into two categories according to their sources: exogenous pyrogens (such as pyrogenic substances of various foreign pathogens such as bacteria, viruses, fungi, etc.) and certain endogenous products (such as antigen-antibody complexes, steroids and massive destruction of tissues in the body, etc.).

[0004] Modern medicine believes that fever can affect the body's material, physiological and defensive functions. For every 1.0°C increase in body temperature, the basal metabolic rate increases by 13%. In a fever state, the consumption of sugar, fat, protein and various vitamins increases. If the child has a long-term fever without the corresponding nutrition supplement, the child will consume his own substances, lose weight and become emaciated. In addition, the increase in evaporation of water from the skin and respiratory tract during the high fever period and the heavy sweating during the fever-reducing period lead to a large loss of water. In severe cases, it can cause dehydration and electrolyte imbalance, and even endanger life. Fever can increase the excitability of the central nervous system. Especially when the fever is high, the child may experience irritability, delirium, hallucinations, etc.

[0005] Because the nervous system of children is not yet fully developed, fever in infancy and early childhood is more likely to cause febrile convulsions than in other periods. Some children with high fever may also show symptoms of nervous system inhibition such as apathy and drowsiness. Heart rate increases during fever, and the heart rate increases by about 18 beats / min for every 1.0℃ increase in body temperature. Within a certain limit, an increase in heart rate can increase cardiac output, but if it exceeds the limit, cardiac output will decrease instead. Fever will also accelerate and deepen breathing, and increase insensible water loss through the respiratory tract. During fever, the secretion of digestive juices decreases, and the activity of various digestive enzymes decreases, resulting in symptoms such as loss of appetite, dry oral mucosa, abdominal distension, and constipation. The impact of fever on the body's defense function has both advantages and disadvantages. Moderate fever can enhance the function of certain immune cells and improve the host's defense against pathogens or tumors, but persistent high fever can induce cell degeneration and necrosis, and even fever-related cytokine storms, which are life-threatening.

[0006] At present, Western medicine usually chooses a drug-based antipyretic strategy based on the results of fever assessment and the primary disease, if antipyretic treatment is needed. Clinically, when a child over 2 months old has a body temperature ≥ 38.2°C and is obviously unwell, antipyretics can be used. Acetaminophen or ibuprofen is recommended for high fever. In addition, other drugs such as analgin, acetylsalicylic acid, phenylbutazone, hydroxyphenylbutazone, indomethacin, aspirin, lysine, nimesulide, aminopyrine, etc. can be used as antipyretics for adults to reduce fever.

[0007] Although the above drugs have obvious antipyretic effects, they cannot change the course of the disease, let alone cure the disease. They are only symptomatic treatments to relieve discomfort. Moreover, these drugs may also produce many adverse reactions, such as rash, urticaria, drug fever, granulocytopenia, etc., and may also have many side effects on the liver, kidneys and digestive system. Western medicine treatment cannot fully consider the differences between individual children, nor the mutual influence between various parts of the human body, so the scope of application is very limited. Summary of the invention

[0008] The purpose of this application is to provide a Chinese medicine composition, preparation and preparation method for treating exogenous fever in children that is non-toxic, has few adverse reactions and has good antipyretic effect. To this end, this application adopts the following technical solutions:

[0009] In a first aspect, the present application provides a traditional Chinese medicine composition for treating exogenous fever in children, comprising the following components in parts by weight:

[0010] 10-120 parts of Radix Isatidis, 5-50 parts of Fructus Forsythiae, 5-50 parts of Radix Puerariae, 5-50 parts of Radix Scutellariae, 5-50 parts of Cortex Lycii, 5-50 parts of Radix Gentianae, 10-120 parts of Gypsum, 5-50 parts of Artemisia Annua, 5-50 parts of Radix Bupleuri, 5-50 parts of Gardeniae, and 5-50 parts of Radix Glycyrrhizae.

[0011] In at least one embodiment, the Chinese medicine composition comprises the following components in parts by weight:

[0012] 30 parts of Radix Isatidis, 15 parts of Fructus Forsythiae, 15 parts of Radix Puerariae, 15 parts of Radix Scutellariae, 15 parts of Cortex Lycii, 15 parts of Radix Gentianae, 30 parts of Gypsum, 15 parts of Artemisia Annua, 15 parts of Radix Bupleuri, 15 parts of Gardeniae, and 10 parts of Radix Glycyrrhizae.

[0013] In a second aspect, the present application provides a Chinese medicine preparation, which is prepared using the above-mentioned Chinese medicine composition as the raw material.

[0014] In at least one embodiment, the traditional Chinese medicine preparation further comprises pharmaceutically acceptable excipients.

[0015] In at least one embodiment, the dosage form of the Chinese medicine preparation is decoction, oral liquid, drops, ointment, pills, powder, tablets or capsules.

[0016] In a third aspect, the present application provides a first method for preparing the above-mentioned traditional Chinese medicine preparation, comprising:

[0017] Weigh each component of the Chinese medicine composition according to the ratio, add 5 to 15 times the total weight of the raw materials in water, soak for 20 to 60 minutes, decoct with water 1 to 3 times, each time for 1 to 2 hours, filter, concentrate the filtrate, cool, and obtain a concentrate;

[0018] Add 1.5 to 2.5 times the amount of ethanol to the cooled concentrated solution 1, stir, let stand, filter, recover ethanol from the filtrate, and concentrate to obtain concentrated solution 2;

[0019] Add flavoring agents and preservatives to the concentrated solution 2, boil and dissolve, add distilled water to make up the volume, filter, and the obtained filtrate is the traditional Chinese medicine preparation.

[0020] In at least one embodiment, the flavoring agent is sucrose, and the preservative is ethylparaben.

[0021] In a fourth aspect, the present application provides another method for preparing the above-mentioned traditional Chinese medicine preparation, comprising:

[0022] Take Artemisia annua, soak it in water, and then obtain Artemisia annua volatile oil by steam reflux extraction;

[0023] Take gypsum, soak it in water, boil it in water and filter it to obtain filtrate 1;

[0024] Take Radix Isatidis, Radix Puerariae, Radix Scutellariae, Radix Bupleuri, and Radix Glycyrrhizae, soak them in water, decoct them in water, precipitate them with ethanol, and filter them to obtain filtrate 2;

[0025] Take Gardenia jasminoides and Forsythia suspensa, soak them in ethanol solution, and then extract them by percolation with ethanol solution to obtain an extract;

[0026] Taking Gentiana macrophylla and Lycium bark, soaking them in ethanol solution, performing ultrasonic-assisted extraction, filtering, and obtaining filtrate three;

[0027] The filtrate 1, filtrate 2, extract and filtrate 3 are combined, heated and concentrated, and the Artemisia annua volatile oil is added to obtain the traditional Chinese medicine preparation.

[0028] In at least one embodiment, the Artemisia annua is soaked in water for 0.5 to 24 hours.

[0029] In at least one embodiment, the raw gypsum is soaked in water for 0.5 to 48 hours and boiled in water for 0.5 to 2 hours.

[0030] In at least one embodiment, the Radix Isatidis, Radix Puerariae, Radix Scutellariae, Radix Bupleuri and Radix Glycyrrhizae are soaked in water for 0.1 to 48 hours and decocted in water for 0.5 to 1 hour.

[0031] In at least one embodiment, the Gardenia and Forsythia are soaked in an ethanol solution for 0.1 to 24 hours, and then extracted by percolation using an ethanol solution with a volume concentration of 30% to 70%.

[0032] In at least one embodiment, the qinjiao and ligupi are soaked in an ethanol solution for 0.1 to 24 hours, and ultrasonic assisted extraction is performed with a frequency of 20 kHz to 50 kHz for 0.5 to 2 hours.

[0033] This application can at least achieve the following beneficial effects:

[0034] The present application provides a Chinese medicine composition for treating exogenous fever in children. The composition can be made into a Chinese medicine preparation for oral administration. After taking the medicine, the fever can be reduced in a short time, the efficacy is good, and the effect is fast, which avoids the resistance of children during intravenous and intramuscular injections, causing difficulties in treatment, and is conducive to promotion and popularization; moreover, the medicine of the present application is non-toxic, has few adverse reactions, and has a good antipyretic effect. The preparation method of the Chinese medicine preparation is improved on the basis of traditional decoction, and the steps are concise, which is conducive to promotion and popularization. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] One or more embodiments of the present application will now be described, by way of example only, with reference to the accompanying drawings, in which:

[0036] Figure 1 A flowchart of the first method for preparing a Chinese medicine preparation provided in this application;

[0037] Figure 2 This is a flowchart of the second method for preparing a Chinese medicine preparation provided in this application. DETAILED DESCRIPTION

[0038] The present application will be described in detail below with reference to the exemplary embodiments in the accompanying drawings. However, it should be understood that the present application can be implemented in a variety of different forms and should not be construed as being limited to the embodiments described herein. These embodiments are provided here to make the disclosure of the present application more complete and to fully convey the concept of the present application to those skilled in the art.

[0039] First, the present application provides a traditional Chinese medicine composition for treating exogenous fever in children, which includes the following components in parts by weight: 10-120 parts of Isatis root, 5-50 parts of Forsythia suspensa, 5-50 parts of Pueraria root, 5-50 parts of Scutellaria baicalensis, 5-50 parts of Lycium bark, 5-50 parts of Gentiana macrophylla, 10-120 parts of Gypsum, 5-50 parts of Artemisia annua, 5-50 parts of Bupleurum chinense, 5-50 parts of Gardenia jasminoides, and 5-50 parts of Licorice.

[0040] The above components are conventional Chinese medicine raw materials in this field, and their common sources are as follows:

[0041] Isatis root is the dried root of Isatis indigotica Fort., a plant of the cruciferous family. Remove impurities, wash, moisten thoroughly, cut into thick slices, and dry. It is bitter and cold in nature. It enters the heart and stomach meridians. It clears away heat and detoxifies, cools blood and relieves sore throat. It is used for epidemic fever, fever and sore throat, fever and toxic spots, mumps, sore throat, red sha, big head plague, erysipelas, and carbuncle.

[0042] Forsythia suspensa (Thunb.) Vahl is a dried fruit of the Oleaceae plant. It is bitter and slightly cold in nature. It enters the lung, heart and small intestine meridians. It clears away heat and detoxifies, reduces swelling and resolves stagnation, and evacuates wind-heat. It is used for carbuncle, scrofula, breast carbuncle, erysipelas, wind-heat cold, the initial stage of febrile disease, warm and heat entering the Ying, high fever and thirst, coma and rash, and hot stranguria and astringent pain.

[0043] Pueraria root is the dried root of Pueraria lobata (Willd.) Ohwi, a plant of the Leguminosae family. Remove impurities, wash, moisten thoroughly, cut into thick slices, and dry in the sun. It is sweet, spicy, and cool in nature. It enters the spleen, stomach, and lung meridians. It relieves muscle and reduces fever, promotes the production of body fluids and quenches thirst, clears rashes, raises yang and stops diarrhea, promotes blood circulation and activates collaterals, and clears alcohol poisoning. It is used for exogenous fever and headache, stiff neck and back pain, thirst, thirst, measles that does not clear up, dysentery, diarrhea, dizziness and headache, hemiplegia caused by stroke, chest pain, and alcohol poisoning.

[0044] Scutellaria baicalensis is the dried root of Scutellaria baicalensis Georgi, a plant of the Labiatae family. Remove impurities from the Scutellaria baicalensis slices, boil them in boiling water for 10 minutes, take them out, steam them thoroughly, slice them thinly, and dry them; or steam them for half an hour, take them out, slice them thinly, and dry them. It is bitter and cold in nature. It enters the lung, gallbladder, spleen, large intestine, and small intestine meridians. It clears away heat and dries dampness, purges fire and detoxifies, stops bleeding, and stabilizes the fetus. It is used for damp-heat, summer dampness, chest tightness and nausea, damp-heat fullness, diarrhea, jaundice, lung heat cough, high fever and thirst, blood heat vomiting and bleeding, carbuncle swelling and sore, and fetal movement disorder.

[0045] Di Gu Pi is the dried root bark of Lycium chinense Mill. or Lycium barbarum L. of the Solanaceae family. Remove impurities and residual pith, wash, and dry in the sun or at low temperature. It is sweet and cold in nature. It enters the lung, liver, and kidney meridians. It cools the blood and removes steam, clears the lungs and reduces fire. It is used for yin deficiency, night sweats due to bone steaming, cough due to lung heat, hemoptysis, epistaxis, and internal heat and thirst.

[0046] Gentiana macrophylla is the dried root of Gentiana macrophylla Pall., Gentianastraminea Maxim., Gentiana crassicaulis Duthie ex Burk. or Gentiana dahurica Fisch. of Gentianaceae. Remove impurities, wash, soak, cut into thick slices, and dry. It is pungent, bitter, and neutral in nature and flavor. It enters the stomach, liver, and gallbladder meridians. It can dispel rheumatism, clear damp-heat, stop arthralgia, and reduce deficiency-heat. It is used for rheumatic arthralgia, hemiplegia due to stroke, muscle spasm, joint pain, damp-heat jaundice, bone steaming and tidal fever, and fever due to malnutrition in children.

[0047] Gypsum is a sulfate mineral gypsum, mainly containing hydrated calcium sulfate (CaSO4·2H2O). Gypsum is crushed, and the stones are removed, and then crushed into coarse powder. It is sweet and spicy in nature and very cold. It enters the lung and stomach meridians. It clears away heat and purges fire, relieves restlessness and quenches thirst. It is used for exogenous febrile diseases, high fever and thirst, lung heat and cough, hyperactivity of stomach fire, headache, and toothache.

[0048] Artemisia annua L. is the dried aerial part of Artemisia annua L., a plant of the Asteraceae family. Remove impurities, spray with clean water, moisten slightly, cut into sections, and dry. It is bitter, pungent, and cold in nature and flavor. It enters the liver and gallbladder meridians. It clears away heat from the deficiency, removes bone steaming, relieves summer heat, stops malaria, and relieves jaundice. It is used for warm pathogens damaging yin, night heat and morning coolness, yin deficiency fever, bone steaming and fatigue fever, summer heat fever, malaria cold and heat, and damp-heat jaundice.

[0049] Bupleurum chinense DC. or Bupleurumscorzonerifolium Willd. of the Apiaceae family. Remove impurities and residual stems, wash, soak, cut into thick slices, and dry. It is pungent, bitter, and slightly cold in nature. It enters the liver, gallbladder, and lung meridians. It can dissipate heat, relieve liver depression, and raise Yang Qi. It is used for colds and fever, alternating cold and heat, chest and flank pain, irregular menstruation, uterine prolapse, and rectal prolapse.

[0050] Gardenia is the dried mature fruit of Gardenia jasminoides Ellis, a plant of the Rubiaceae family. Remove impurities and grind. It is bitter and cold in nature. It enters the heart, lung, and triple burner meridians. It can relieve fire and relieve restlessness, clear away heat and dampness, cool blood and detoxify; it can be used externally to reduce swelling and relieve pain. It is used for restlessness caused by febrile diseases, jaundice caused by dampness and heat, astringent pain caused by stranguria, vomiting and bleeding caused by blood heat, red and swollen eyes, and fire poison sores; it can also be used externally to treat sprains and contusions.

[0051] Licorice is the dried root and rhizome of Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat. or Glycyrrhiza glabra L. of the Leguminosae family. Remove impurities, wash, moisten thoroughly, cut into thick slices, and dry. It is sweet and flat in nature. It enters the heart, lung, spleen, and stomach meridians. It nourishes the spleen and replenishes qi, clears away heat and detoxifies, removes phlegm and relieves cough, relieves pain, and harmonizes various medicines. It is used for spleen and stomach weakness, fatigue, palpitations and shortness of breath, cough with sputum, acute pain in the abdomen and limbs, carbuncle, sore, and relieves drug toxicity and potency.

[0052] The above composition is most commonly prepared as a decoction, and the dosage of the medicine in the prescription can be flexibly adjusted according to the individual conditions of the patient. Here, the inventor also provides a most commonly used ratio, that is, the Chinese medicine composition for treating exogenous fever in children, which includes the following components by weight: 30 parts of Radix Isatidis, 15 parts of Fructus Forsythiae, 15 parts of Radix Puerariae, 15 parts of Radix Scutellariae, 15 parts of Cortex Lycii, 15 parts of Radix Gentianae, 30 parts of Gypsum, 15 parts of Artemisia Annua, 15 parts of Radix Bupleuri, 15 parts of Gardeniae, and 10 parts of Licorice.

[0053] The above composition can be used as a raw material medicine to prepare not only a decoction, but also other common Chinese patent medicine preparations according to conventional processes. The Chinese patent medicine preparations include liquid preparations, semisolid preparations or solid preparations. These forms of pharmaceutical preparations contain the Chinese medicine composition of the present application or its extract as an active ingredient, and may also contain pharmaceutically acceptable excipients. The active ingredient can be compounded with a commonly used non-toxic pharmaceutical excipient to prepare a decoction, oral liquid, drops, ointment, pill, powder, tablet or capsule and any dosage form that can be used. The auxiliary materials of the Chinese medicine preparation of the present application include but are not limited to solvents, propellants, solubilizers, cosolvents, emulsifiers, colorants, adhesives, disintegrants, fillers, lubricants, wetting agents, osmotic pressure regulators, stabilizers, glidants, flavoring agents, preservatives, suspending agents, coating materials, fragrances, anti-adhesive agents, integrators, penetration enhancers, pH regulators, buffers, plasticizers, surfactants, foaming agents, defoamers, thickeners, inclusion agents, humectants, absorbents, diluents, flocculants and deflocculating agents, filter aids, release retardants, etc. More specifically, the auxiliary materials include but are not limited to talc, water, ethanol, glucose, honey, lactose, gum arabic, gelatin, mannitol, starch, magnesium trisilicate, keratin, colloidal silicon, and the like.

[0054] Secondly, refer to Figure 1 The present application provides a method for preparing the above-mentioned Chinese medicine preparation, comprising the following steps:

[0055] 1) Weighing each component of the Chinese medicine composition according to the ratio, adding 5 to 15 times of water in weight of the total weight of the raw materials, soaking for 20 to 60 minutes, decocting with water 1 to 3 times, each time for 1 to 2 hours, filtering, concentrating the filtrate, cooling, and obtaining a concentrated solution 1;

[0056] 2) adding 1.5 to 2.5 times the amount of ethanol to the cooled concentrated solution 1, stirring, standing, filtering, recovering ethanol from the filtrate, and concentrating to obtain concentrated solution 2;

[0057] 3) Add a flavoring agent (sucrose) and a preservative (ethyl paraben) to the concentrated solution 2, boil and dissolve, add distilled water to make up the volume, filter, and the obtained filtrate is the traditional Chinese medicine preparation.

[0058] Finally, reference Figure 2 The present application also provides another method for preparing the above-mentioned Chinese medicine preparation, comprising the following steps:

[0059] 1) taking Artemisia annua, soaking it in water, and then extracting it by steam reflux method to obtain Artemisia annua volatile oil;

[0060] 2) taking gypsum, soaking it in water, boiling it in water and filtering it to obtain filtrate 1;

[0061] 3) soaking Radix Isatidis, Radix Puerariae, Radix Scutellariae, Radix Bupleuri, and Radix Glycyrrhizae in water, decocting with water, precipitating with ethanol, and filtering to obtain filtrate 2;

[0062] 4) soaking Gardenia jasminoides and Forsythia suspensa in an ethanol solution, and then extracting by percolation with the ethanol solution to obtain an extract;

[0063] 5) taking Gentiana macrophylla and Lycium bark, soaking them in an ethanol solution, performing ultrasonic-assisted extraction, filtering, and obtaining a filtrate three;

[0064] 6) combining the filtrate 1, the filtrate 2, the extract and the filtrate 3, heating and concentrating them, adding the Artemisia annua volatile oil, and obtaining the traditional Chinese medicine preparation.

[0065] exist Figure 2 In the preparation method, the Artemisia annua is soaked in water for 0.5 to 24 hours. The raw gypsum is soaked in water for 0.5 to 48 hours and decocted in water for 0.5 to 2 hours. The Radix Isatidis, Radix Puerariae, Radix Scutellariae, Radix Bupleuri and Radix Glycyrrhizae are soaked in water for 0.1 to 48 hours and decocted in water for 0.5 to 1 hour. The Gardenia and Fructus Forsythiae are soaked in ethanol solution for 0.1 to 24 hours and extracted by percolation with ethanol solution of 30% to 70% volume concentration. The Gentiana macrophylla and Cortex Lycii are soaked in ethanol solution for 0.1 to 24 hours and extracted by ultrasonic assisted extraction with a frequency of 20kHz to 50kHz for 0.5 to 2 hours.

[0066] Compared to Figure 1 The preparation method has the following advantages:

[0067] 1. Artemisia annua is a raw material medicine containing a large amount of volatile oil components. Extracting the essential oil first can prevent volatilization and loss during the heating step before use;

[0068] 2. Gypsum is a mineral medicinal material and should be decocted first to ensure that the effective ingredients are fully decocted;

[0069] 3. Radix Isatidis, Radix Puerariae, Radix Scutellariae, Radix Bupleuri, and Radix Glycyrrhizae are rhizomes of Chinese medicine with solid texture. They need to be fully soaked and boiled for a sufficient time to ensure that the effective ingredients are boiled out. The alcohol precipitation method can remove non-medicinal impurities.

[0070] 4. Gardenia and Forsythia are fruit-based medicinal materials, and the percolation method can collect components that are not conducive to heating;

[0071] 5. Gentiana macrophylla and Radix Lycii are skin-based medicinal materials, and ultrasonic method is conducive to the full dissolution of the effective ingredients;

[0072] 6. After all the components are mixed, heat and concentrate them and finally add the volatile oil. This will help the volatile oil to exert its medicinal effects and enhance the therapeutic effect.

[0073] The treatment principles of the above-mentioned Chinese medicine composition and Chinese medicine preparation are as follows:

[0074] The medicinal properties are mainly cold and cool. In the formula, the root of kudzu is pungent and cool in nature, entering the Yangming meridian, penetrating muscle heat externally and clearing stagnant heat internally; the root of bupleurum is pungent and cold in nature, entering the Shaoyang meridian, and is good at removing evil qi, relieving the exterior and reducing fever. The two medicines complement each other, and their power of relieving muscle heat and clearing heat is prominent, so they are used together as the main medicine. Scutellaria baicalensis, gypsum, and forsythia suspensa are all ministerial medicines for clearing internal heat and relieving heat accumulated in the lungs and stomach. In addition, the root of kudzu is combined with gypsum to clear the evil heat of the Yangming meridian; the root of bupleurum is combined with scutellaria baicalensis to clear the evil heat of the Shaoyang meridian. This combination treats both Yang meridians, and mainly treats the Yangming meridian. The root of isatis clears heat and detoxifies, and cools the blood. Gardenia jasminoides clears fire and relieves restlessness, clears heat and removes dampness. The root of qinjiao removes false heat and removes bone steaming. Artemisia annua is bitter, cold, and fragrant, and it can dispel filth and dampness, and clear the evil qi of the Shaoyang meridian. The root of rehmannia root clears the lungs and reduces fire, nourishes yin and moistens dryness, and are all adjuvant medicines. Licorice clears away heat and detoxifies, removes phlegm and relieves cough, relieves pain, and harmonizes various medicines. It is a guiding medicine. The whole prescription is mainly pungent, bitter, and cold. Pungent can disperse evil spirits, bitter can clear and drain, and is used for fire and heat inflammation, while cold can clear heat and purge fire, cool blood and detoxify. Overall, according to the combined effects of the drugs, it can effectively control symptoms such as fever in children and improve the quality of life of children.

[0075] Efficacy of the above composition and preparation: The Chinese medicine composition and preparation of the present application have been clinically verified for many years and have the effects of clearing away heat, purging fire and detoxifying. Indications: exogenous fever, headache, body pain, nasal congestion, runny nose, cough and other symptoms, can reduce the inflammatory response in the body, relieve cold headache and fever.

[0076] In addition, the present application also provides a number of specific embodiments, further illustrating the raw material composition and preparation method of the above-mentioned traditional Chinese medicine preparation for treating exogenous fever in children, specifically:

[0077] Example 1

[0078] 1) Weigh the following raw materials by weight: 30 parts of Radix Isatidis, 15 parts of Fructus Forsythiae, 15 parts of Radix Puerariae, 15 parts of Radix Scutellariae, 15 parts of Cortex Lycii, 15 parts of Radix Gentianae, 30 parts of Gypsum, 15 parts of Artemisia Annua, 15 parts of Radix Bupleuri, 15 parts of Gardeniae, and 10 parts of Radix Glycyrrhizae.

[0079] 2) Take Artemisia annua, soak it in water for 12 hours, and then obtain Artemisia annua volatile oil by steam reflux extraction.

[0080] 3) Take raw gypsum, soak it in water for 24 hours, boil it in water for 1 hour, and then filter it to obtain filtrate 1.

[0081] 4) Take Radix Isatidis, Radix Puerariae, Radix Scutellariae, Radix Bupleuri, and Radix Glycyrrhizae, soak them in water for 24 hours, decoct them in water for 1 hour, precipitate them with ethanol, and filter them to obtain filtrate 2.

[0082] 5) Take Gardenia jasminoides and Forsythia suspensa, soak them in ethanol solution for 12 hours, and then extract them by percolation with 50% ethanol solution to obtain an extract.

[0083] 6) Take Gentiana macrophylla and Lycium bark, soak them in ethanol solution, extract them with 50 kHz ultrasonic assisted extraction for 1 hour, filter and obtain filtrate three.

[0084] 7) combining the filtrate 1, the filtrate 2, the extract and the filtrate 3, heating and concentrating them, adding the Artemisia annua volatile oil, and obtaining the traditional Chinese medicine preparation.

[0085] Example 2

[0086] 1) Weigh the following raw materials by weight: 10 parts of Radix Isatidis, 50 parts of Fructus Forsythiae, 5 parts of Radix Puerariae, 50 parts of Radix Scutellariae, 5 parts of Cortex Lycii, 50 parts of Radix Gentianae, 10 parts of Gypsum, 50 parts of Artemisia Annua, 5 parts of Radix Bupleuri, 50 parts of Gardeniae, and 5 parts of Licorice.

[0087] 2) Take Artemisia annua, soak it in water for 24 hours, and then obtain Artemisia annua volatile oil by steam reflux extraction.

[0088] 3) Take raw gypsum, soak it in water for 0.5 h, boil it in water for 2 h, and then filter it to obtain filtrate 1.

[0089] 4) Take Radix Isatidis, Radix Puerariae, Radix Scutellariae, Radix Bupleuri, and Radix Glycyrrhizae, soak them in water for 0.1 h, decoct them in water for 1 h, precipitate them with ethanol, and filter them to obtain filtrate 2.

[0090] 5) Take Gardenia jasminoides and Forsythia suspensa, soak them in ethanol solution for 0.1 h, and then extract them by percolation with 70% ethanol solution to obtain an extract.

[0091] 6) Take Gentiana macrophylla and Lycium bark, soak them in ethanol solution, extract them with 20 kHz ultrasonic assisted extraction for 2 h, filter and obtain filtrate three.

[0092] 7) combining the filtrate 1, the filtrate 2, the extract and the filtrate 3, heating and concentrating them, adding the Artemisia annua volatile oil, and obtaining the traditional Chinese medicine preparation.

[0093] Example 3

[0094] 1) Weigh the following raw materials by weight: 120 parts of Radix Isatidis, 5 parts of Fructus Forsythiae, 50 parts of Radix Puerariae, 5 parts of Radix Scutellariae, 50 parts of Cortex Lycii, 5 parts of Radix Gentianae Macrophyllae, 120 parts of Gypsum, 5 parts of Artemisia Annua, 50 parts of Radix Bupleuri, 5 parts of Gardeniae, and 50 parts of Radix Glycyrrhizae.

[0095] 2) Take Artemisia annua, soak it in water for 0.5 h, and then obtain Artemisia annua volatile oil by steam reflux extraction.

[0096] 3) Take raw gypsum, soak it in water for 48 hours, boil it in water for 0.5 hours, and then filter it to obtain filtrate 1.

[0097] 4) Take Radix Isatidis, Radix Puerariae, Radix Scutellariae, Radix Bupleuri, and Radix Glycyrrhizae, soak them in water for 48 hours, decoct them in water for 0.5 hours, precipitate them with ethanol, and filter them to obtain filtrate 2.

[0098] 5) Take Gardenia jasminoides and Forsythia suspensa, soak them in ethanol solution for 24 hours, and then extract them by percolation with 30% ethanol solution to obtain an extract.

[0099] 6) Take Gentiana macrophylla and Lycium bark, soak them in ethanol solution, extract them by 50 kHz ultrasonic assisted extraction for 0.5 h, filter and obtain filtrate three.

[0100] 7) combining the filtrate 1, the filtrate 2, the extract and the filtrate 3, heating and concentrating them, adding the Artemisia annua volatile oil, and obtaining the traditional Chinese medicine preparation.

[0101] Example 4

[0102] 1) Weigh the following raw materials by weight: 80 parts of Radix Isatidis, 50 parts of Fructus Forsythiae, 5 parts of Radix Puerariae, 30 parts of Scutellariae, 50 parts of Cortex Lycii, 5 parts of Gentiana Macrophyllae, 50 parts of Gypsum, 30 parts of Artemisia Annua, 6 parts of Radix Bupleuri, 10 parts of Gardeniae, and 40 parts of Licorice.

[0103] 2) Take Artemisia annua, soak it in water for 2 hours, and then obtain Artemisia annua volatile oil by steam reflux extraction.

[0104] 3) Take raw gypsum, soak it in water for 24 hours, boil it in water for 1 hour, and then filter it to obtain filtrate 1.

[0105] 4) Take Radix Isatidis, Radix Puerariae, Radix Scutellariae, Radix Bupleuri, and Radix Glycyrrhizae, soak them in water for 40 hours, decoct them in water for 0.75 hours, precipitate them with ethanol, and filter them to obtain filtrate 2.

[0106] 5) Take Gardenia jasminoides and Forsythia suspensa, soak them in ethanol solution for 10 hours, and then extract them by percolation with 50% ethanol solution to obtain an extract.

[0107] 6) Take Gentiana macrophylla and Lycium bark, soak them in ethanol solution, extract them by 40 kHz ultrasonic assisted extraction for 1.5 h, filter and obtain filtrate three.

[0108] 7) combining the filtrate 1, the filtrate 2, the extract and the filtrate 3, heating and concentrating them, adding the Artemisia annua volatile oil, and obtaining the traditional Chinese medicine preparation.

[0109] Example 5

[0110] 1) Weigh the following raw materials by weight: 40 parts of Radix Isatidis, 10 parts of Fructus Forsythiae, 45 parts of Radix Puerariae, 20 parts of Scutellariae, 30 parts of Cortex Lycii, 50 parts of Gentiana Macrophyllae, 10 parts of Gypsum, 5 parts of Artemisia Annua, 50 parts of Radix Bupleuri, 30 parts of Gardeniae, and 20 parts of Licorice.

[0111] 2) Take Artemisia annua, soak it in water for 5 hours, and then obtain Artemisia annua volatile oil by steam reflux extraction.

[0112] 3) Take gypsum, soak it in water for 10 hours, boil it in water for 2 hours, and then filter it to obtain filtrate 1.

[0113] 4) Take Radix Isatidis, Radix Puerariae, Radix Scutellariae, Radix Bupleuri, and Radix Glycyrrhizae, soak them in water for 12 hours, decoct them in water for 1 hour, precipitate them with ethanol, and filter them to obtain filtrate 2.

[0114] 5) Take Gardenia jasminoides and Forsythia suspensa, soak them in ethanol solution for 12 hours, and then extract them by percolation with 30% ethanol solution to obtain an extract.

[0115] 6) Take Gentiana macrophylla and Lycium bark, soak them in ethanol solution, extract them by 50 kHz ultrasonic assisted extraction for 0.5 h, filter and obtain filtrate three.

[0116] 7) combining the filtrate 1, the filtrate 2, the extract and the filtrate 3, heating and concentrating them, adding the Artemisia annua volatile oil, and obtaining the traditional Chinese medicine preparation.

[0117] Example 6

[0118] 1) Weigh the following raw materials by weight: 30 parts of Radix Isatidis, 15 parts of Fructus Forsythiae, 15 parts of Radix Puerariae, 15 parts of Radix Scutellariae, 15 parts of Cortex Lycii, 15 parts of Radix Gentianae, 30 parts of Gypsum, 15 parts of Artemisia Annua, 15 parts of Radix Bupleuri, 15 parts of Gardeniae, and 10 parts of Radix Glycyrrhizae.

[0119] 2) Add 10 times the total weight of the raw material water, soak for 40 minutes, decoct twice with water, each time for 1.5 hours, filter, concentrate the filtrate to 500 ml, cool, and obtain concentrated solution 1;

[0120] 3) adding 2 times the weight of ethanol to the cooled concentrated solution 1, stirring, standing, filtering, recovering ethanol from the filtrate, and concentrating to obtain concentrated solution 2;

[0121] 4) Add a flavoring agent (sucrose) and a preservative (ethyl paraben) to the concentrated solution 2, boil and dissolve, add distilled water to make the volume 1000 ml, filter, and the obtained filtrate is the traditional Chinese medicine preparation.

[0122] Example 7

[0123] 1) Weigh the following raw materials by weight: 10 parts of Radix Isatidis, 50 parts of Fructus Forsythiae, 5 parts of Radix Puerariae, 50 parts of Radix Scutellariae, 5 parts of Cortex Lycii, 50 parts of Radix Gentianae, 10 parts of Gypsum, 50 parts of Artemisia Annua, 5 parts of Radix Bupleuri, 50 parts of Gardeniae, and 5 parts of Licorice.

[0124] 2) Add 15 times the total weight of the API in water, soak for 20 minutes, decoct with water 3 times, 1 hour each time, filter, concentrate the filtrate to 500 ml, cool, and obtain concentrate 1;

[0125] 3) adding 2.5 times the weight of ethanol to the cooled concentrated solution 1, stirring, standing, filtering, recovering ethanol from the filtrate, and concentrating to obtain concentrated solution 2;

[0126] 4) Add a flavoring agent (sucrose) and a preservative (ethyl paraben) to the concentrated solution 2, boil and dissolve, add distilled water to make the volume 1000 ml, filter, and the obtained filtrate is the traditional Chinese medicine preparation.

[0127] Example 8

[0128] 1) Weigh the following raw materials by weight: 120 parts of Radix Isatidis, 5 parts of Fructus Forsythiae, 50 parts of Radix Puerariae, 50 parts of Radix Scutellariae, 50 parts of Cortex Lycii, 5 parts of Radix Gentianae Macrophyllae, 120 parts of Gypsum, 5 parts of Artemisia Annua, 50 parts of Radix Bupleuri, 5 parts of Gardeniae, and 50 parts of Radix Glycyrrhizae.

[0129] 2) Add 5 times the total weight of the raw material drug in water, soak for 60 minutes, decoct once with water for 2 hours each time, filter, concentrate the filtrate to 500 ml, cool, and obtain concentrated solution 1;

[0130] 3) adding 1.5 times the weight of ethanol to the cooled concentrated solution 1, stirring, standing, filtering, recovering ethanol from the filtrate, and concentrating to obtain concentrated solution 2;

[0131] 4) Add a flavoring agent (sucrose) and a preservative (ethyl paraben) to the concentrated solution 2, boil and dissolve, add distilled water to make the volume 1000 ml, filter, and the obtained filtrate is the traditional Chinese medicine preparation.

[0132] In comparison, due to the difference in preparation methods, and after experimental comparison and clinical comparison by the applicant, the efficacy of the Chinese medicine preparations prepared in Examples 1-5 is better than that of the preparations prepared in Examples 6-8, that is, Figure 2 The preparation method in the present invention has a better effect than Figure 1 The preparation method in Figure 1 The method steps in the present invention are relatively simple, and each has its own advantages and disadvantages. The therapeutic effect achieved by the present invention will be further illustrated by specific experimental examples.

[0133] Test Example 1: Animal Experiment

[0134] Lipopolysaccharide (LPS) and dry yeast were used as pyrogens to prepare fever model rats, and the differences in the antipyretic effects of different doses of Chinese medicine compositions on different fever model rats were observed, providing a preliminary basis for the selection of effective prescriptions for the clinical treatment of febrile diseases.

[0135] The specific experimental process is:

[0136] 1. Preparation of test solution

[0137] Test solution: prepared according to the preparation method of Example 1 above.

[0138] Aspirin solution: Take 10 enteric-coated aspirin tablets (100 mg / tablet), put them in a mortar, crush them, and add 100 mL of normal saline to dissolve them to prepare a solution with a concentration of 10 mg / mL;

[0139] Preparation of LPS solution: Resuspend 1 mg of LPS in 1 ml of sterile balanced salt solution to prepare a 1 mg / ml LPS stock suspension.

[0140] Preparation of dry yeast suspension: Before the experiment, weigh 50.0 g of dry yeast, place it in a mortar, add an appropriate amount of sterile saline, and slowly grind it. After grinding evenly, slowly transfer it to a volumetric flask and dilute it to 250 mL with sterile saline to prepare a 20% dry yeast suspension.

[0141] 2. Rat Adaptability Test

[0142] The rats were placed in a laboratory with an ambient temperature of (23±2)℃ and fed normally. The rectal temperature of the rats was measured once a day. Before the measurement, the feces in the rats' rectums were squeezed out, and then a thermometer dipped in vaseline was gently inserted into the anus 2 cm. When the electronic thermometer showed a stable body temperature, it was pulled out and the rats were adapted to the measurement for 2 consecutive days. They were used for the experiment. They were fasted but not watered for 8 hours before the experiment.

[0143] 3. Animal modeling and grouping

[0144] After picric acid labeling, the mice were randomly divided into 8 groups, namely: model groups M1 and M2, aspirin groups A1 and A2, low-dose Chinese medicine combination groups L1 and L2, and high-dose Chinese medicine combination groups H1 and H2, with 5 mice in each group.

[0145] M1, A1, L1, H1 groups: rats were intraperitoneally injected with LPS (20 μg / kg) to induce fever in the animals. At the same time as the model was established, rats in group A1 were intragastrically administered with 125 mg / kg of aspirin dilution; group L1 was administered with 10 mL / kg of low-dose Chinese medicine decoction; group H1 was administered with 20 mL / kg of high-dose Chinese medicine decoction; group M1 was administered with an equal volume of normal saline. Body temperature was measured every 0.5 h after LPS injection and monitored continuously for 10 h.

[0146] M2, A2, L2, H2 groups: rats were subcutaneously injected with 20% dry yeast suspension (10mL / kg) to induce fever in animals, and gavage was given at the same time as modeling. Rats in group A2 were gavaged with 125mg / kg of aspirin diluent; group L2 was gavaged with 10mL / kg of low-dose Chinese medicine decoction; group H2 was gavaged with 20mL / kg of high-dose Chinese medicine decoction; group M2 was gavaged with an equal volume of normal saline. Body temperature was measured every 0.5h after injection of yeast suspension, and monitored continuously for 10h.

[0147] If the rats show symptoms such as low fever followed by high fever, chills, rapid breathing, loss of appetite, significantly reduced activity, and gathering in groups, the model is successfully established.

[0148] 4. Data Processing

[0149] Draw the average body temperature change curve of each group; record the maximum body temperature rise △T (the difference between the body temperature during fever and the basal body temperature).

[0150] 5. Statistical methods

[0151] The data of each group were expressed as mean ± standard deviation, and repeated measures analysis of variance was used for multiple groups of data, and Q test was used for comparison between groups. All data were processed using SPSS27.1 statistical software.

[0152] 6. Experimental Results

[0153] 6.1 Effect of Chinese herbal medicine combination on body temperature changes in LPS-induced fever model in rats

[0154] Compared with the model group, the body temperature of rats in the aspirin group was significantly reduced at 9 observation points between 4.5 and 8.5 hours after LPS injection and administration, with significant differences (P < 0.05 or P < 0.01); the body temperature of rats in the low-dose soup group was significantly reduced at 8 observation points between 4 and 7.5 hours after LPS injection and administration, with significant differences (P < 0.05 or P < 0.01). The body temperature of rats in the high-dose soup group was significantly reduced at 8 observation points between 4.5 and 8 hours after LPS injection and administration, with significant differences (P < 0.05 or P < 0.01). The average body temperature of rats in the high-dose group was lower than that in the low-dose group within 5 to 10 hours, especially at 6 and 6.5 hours, with significant differences (P < 0.05 or P < 0.01). Although the body temperature at other time points was lower than that in the low-dose group, it was not statistically significant (P> 0.05). After administration of the fever-inducing agent LPS, the body temperature of the model group increased significantly, while that of the treatment group decreased to varying degrees, showing significant differences compared with the model group. See Tables 1-3.

[0155] Table 1. Effect of Chinese medicine composition on LPS-induced increase in body temperature in rats (x±s, n=5)

[0156]

[0157] Note: *P<0.05, **P<0.01 compared with M1

[0158] Table 2. Effect of Chinese medicine composition on LPS-induced increase in body temperature in rats (x±s, n=5)

[0159]

[0160] Note: *P<0.05, **P<0.01 compared with M1

[0161] Table 3. Effect of Chinese medicine composition on LPS-induced increase in body temperature in rats (x±s, n=5)

[0162]

[0163] Note: *P<0.05, **P<0.01 compared with M1

[0164] 6.2 Effect of Chinese herbal medicine combination on body temperature changes in dry yeast-induced fever model in rats

[0165] Compared with the model group, the body temperature of the aspirin group at 10 observation points between 5.5 and 10 hours after the injection of yeast suspension and administration was significantly reduced, with significant differences (P < 0.05 or P < 0.01); the body temperature of the low-dose group at 9 observation points between 6 and 10 hours after the injection of yeast suspension was significantly reduced, with significant differences (P < 0.05 or P < 0.01); the body temperature of the high-dose group at 12 observation points between 4.5 and 10 hours after the injection of yeast suspension was significantly reduced, with significant differences (P < 0.05 or P < 0.01). Within 0 to 10 hours, the average body temperature of the rats in the high-dose group was lower than that in the low-dose group, especially at 6 hours, 7 hours, and 7.5 hours, with significant differences (P < 0.05). At other times, although the average body temperature of the rats in the high-dose group was lower than that in the low-dose group, it was not statistically significant (P> 0.05). After administration of the fever-inducing agent, high-activity yeast, the body temperature of the model group first decreased and then increased, and the body temperature of the treatment group decreased to varying degrees after administration, which was significantly different from that of the model group. See Tables 4 to 6 for details.

[0166] Table 4. Effect of Chinese medicine composition on elevated body temperature in rats induced by high-activity yeast (x±s, n=5)

[0167]

[0168] Note: *P<0.05, **P<0.01 compared with M2

[0169] Table 5. Effect of Chinese medicine composition on elevated body temperature of rats induced by high-activity yeast (x±s, n=5)

[0170]

[0171] Note: *P<0.05, **P<0.01 compared with M2

[0172] Table 6. Effect of Chinese medicine composition on elevated body temperature in rats induced by high-activity yeast (x±s, n=5)

[0173]

[0174] Note: *P<0.05, **P<0.01 compared with M2

[0175] 7. Conclusion

[0176] The Chinese medicine composition of the present application is an antipyretic drug, and its comprehensive antipyretic effect has been experimentally verified in rats with different fever models. The experimental results of this study showed that the Chinese medicine composition showed a relatively significant antipyretic effect under different fever models. In the experimental group, the body temperature of the rats dropped significantly after being administered the Chinese medicine composition, and the difference was statistically significant compared with the model group (P < 0.05). This shows that the Chinese medicine composition has a good antipyretic effect on fever symptoms caused by different reasons.

[0177] In addition, by comparing various antipyretic drugs, it was found that there was no statistical significance between the low-dose group and the high-dose group compared with the aspirin group (P>0.05). This shows that the Chinese medicine composition has a certain antipyretic effect, but the mechanism of action is different from that of aspirin, and the antipyretic effect is slower than that of aspirin. In actual clinical applications, the comprehensive antipyretic effect of the Chinese medicine composition can provide doctors and patients with more options during the treatment process, making antipyretic treatment more personalized and effective.

[0178] In summary, the results of this study show that the Chinese medicine composition of the present application has a good comprehensive antipyretic effect in rats with different fever models, and can provide an option for treating different types of febrile diseases.

[0179] Test Example 2: Clinical Trial

[0180] 1. General Information

[0181] A total of 134 children with fever diagnosed with upper respiratory tract infection who were treated in Liuzhou Maternal and Child Health Hospital and Liuzhou Hospital of Guangzhou Women and Children's Medical Center from January 2022 to December 2023 were selected and randomly divided into a control group and a treatment group. There were 66 cases in the control group and 68 cases in the treatment group. The age ranged from 2.5 to 12.8 years, with an average of 6.5±1.8 years. The body temperature before treatment was 38.2-38.9℃ (axillary temperature), with an average of (38.8±0.2)℃. There was no statistically significant difference in age, gender, and body temperature distribution between the two groups (P>0.05), and they were comparable.

[0182] 2. Diagnostic criteria: All are in accordance with the fever diagnostic criteria of the "Guiding Principles for Clinical Research of New Chinese Medicines", "Diagnosis and Efficacy Standards of Chinese Medicine Diseases and Syndromes", and "Diagnostics": ① Rectal temperature ≥ 38℃; ② Axillary temperature ≥ 37.5℃.

[0183] Exclusion criteria: ① patients with liver and kidney dysfunction, hematopoietic system disorders, cardiovascular diseases, and mental illness; ② patients with severe infection; ③ patients diagnosed with immune system diseases, tumors, severe trauma, etc.

[0184] 3. Observation indicators and efficacy evaluation criteria

[0185] Observation index: The patient's body temperature changes were recorded before and after treatment. The body temperature was measured once every 1 hour after taking the medicine, once every 2 hours after the onset of effect (onset time see efficacy evaluation), and once every 4 hours after fever relief (fever relief time see efficacy evaluation).

[0186] Efficacy evaluation criteria: formulated in accordance with the relevant contents of the "Guidelines for Clinical Research of New Chinese Medicines (Trial)". ① Antipyretic onset time: the time required from the start of medication to the body temperature dropping by 0.5℃. ② Antipyretic time: the time required from the start of medication to the body temperature dropping to 37.2℃. ③ Antipyretic treatment effectiveness: a body temperature drop of ≥1℃ within 48 hours after treatment is considered significant, a body temperature drop of ≥0.5℃ is considered effective, and a body temperature drop of <0.5℃ or rebound is considered ineffective.

[0187] Effective rate of antipyretic treatment = the sum of the percentages of markedly effective and effective cases in the total number of cases.

[0188] 4. Statistical methods: SPSS 22.0 software was used for data processing. The data were in accordance with normal distribution and the variance was equal when the t test was used, and the corrected t test was used when the variance was unequal; the count data were tested with the χ2 test. P<0.05 was considered statistically significant.

[0189] 5. Treatment Methods

[0190] Observation group: The above-mentioned Chinese medicine composition for treating fever in children was selected and made into a decoction according to the preparation method (daily dose: 30g of Isatis root, 15g of Forsythia, 15g of Pueraria, 15g of Scutellaria, 15g of Lycium bark, 15g of Gentiana macrophylla, 30g of Gypsum, 15g of Artemisia annua, 15g of Bupleurum, 15g of Gardenia, and 10g of Licorice), which was taken orally, twice a day.

[0191] Control group: The control group received symptomatic treatment based on the clinical manifestations of the patients. Oral ibuprofen suspension drops were taken when necessary, no more than 3 times in 24 hours. Both groups were treated for 3 days and followed up for 3 days.

[0192] 6. Statistical results:

[0193] 6.1 Comparison of maximum body temperature before and after treatment: After treatment, the maximum body temperature of both groups decreased compared with that before treatment (P<0.05), but there was no statistically significant difference between the two groups (P>0.05), see Table 1

[0194] Table 1 Comparison of the highest body temperature of patients with fever in groups 1 and 2 before and after treatment (℃, )

[0195]

[0196] 6.2 Comparison of onset time and antipyretic time of body temperature: The onset time and antipyretic time of the observation group were slightly later than those of the control group, but there was no statistically significant difference between the two groups (P>0.05), see Table 2.

[0197] Table 2. Comparison of temperature onset time and antipyretic time

[0198]

[0199] 6.3 Comparison of the cooling effectiveness of the two groups of children 48 hours after treatment. As shown in Table 3, the observation group had a higher effectiveness than the control group.

[0200] Table 3. Comparison of the effective rate of cooling down in children 48 hours after treatment (%)

[0201]

[0202] 7. Security

[0203] No obvious adverse events occurred in either group of patients during the treatment.

[0204] The results showed that there was no statistically significant difference in the antipyretic efficacy and antipyretic time between the Chinese medicine composition of the present application and ibuprofen suspension (P>0.05). The antipyretic effect of the Chinese medicine composition was relatively stable and long-lasting, without obvious rebound phenomenon, and no obvious adverse reactions were found.

Claims

1. A Chinese medicine composition for treating exogenous fever in children, characterized in that: The composition comprises the following components in parts by weight: 10-120 parts of Radix Isatidis, 5-50 parts of Fructus Forsythiae, 5-50 parts of Radix Puerariae, 5-50 parts of Radix Scutellariae, 5-50 parts of Cortex Lycii, 5-50 parts of Radix Gentianae, 10-120 parts of Gypsum, 5-50 parts of Artemisia Annua, 5-50 parts of Radix Bupleuri, 5-50 parts of Gardeniae, and 5-50 parts of Radix Glycyrrhizae.

2. The Chinese medicine composition according to claim 1, characterized in that: The composition comprises the following components in parts by weight: 30 parts of Radix Isatidis, 15 parts of Fructus Forsythiae, 15 parts of Radix Puerariae, 15 parts of Radix Scutellariae, 15 parts of Cortex Lycii, 15 parts of Radix Gentianae, 30 parts of Gypsum, 15 parts of Artemisia Annua, 15 parts of Radix Bupleuri, 15 parts of Gardeniae, and 10 parts of Radix Glycyrrhizae.

3. A Chinese medicine preparation, characterized in that: The Chinese medicine composition according to claim 1 or 2 is used as the raw material.

4. The Chinese medicine preparation according to claim 3, characterized in that: Also contains pharmaceutically acceptable excipients.

5. A method for preparing the Chinese medicine preparation according to claim 3, characterized in that: include: Weigh each component of the Chinese medicine composition according to the ratio, add 5 to 15 times the total weight of the raw material water, soak for 20 to 60 minutes, decoct with water 1 to 3 times, each time for 1 to 2 hours, filter, concentrate the filtrate, cool, and obtain a concentrate; Add 1.5 to 2.5 times the amount of ethanol to the cooled concentrated solution 1, stir, let stand, filter, recover ethanol from the filtrate, and concentrate to obtain concentrated solution 2; Add flavoring agents and preservatives to the concentrated solution 2, boil and dissolve, add distilled water to make up the volume, filter, and the obtained filtrate is the traditional Chinese medicine preparation.

6. The preparation method according to claim 5, characterized in that: The flavoring agent is sucrose, and the preservative is ethyl paraben.

7. A method for preparing the Chinese medicine preparation according to claim 3, characterized in that: include: Take Artemisia annua, soak it in water, and then obtain Artemisia annua volatile oil by steam reflux extraction; Take gypsum, soak it in water, boil it in water and filter it to obtain filtrate 1; Take Radix Isatidis, Radix Puerariae, Radix Scutellariae, Radix Bupleuri, and Radix Glycyrrhizae, soak them in water, decoct them in water, precipitate them with ethanol, and filter them to obtain filtrate 2; Take Gardenia jasminoides and Forsythia suspensa, soak them in ethanol solution, and then extract them by percolation with ethanol solution to obtain an extract; Taking Gentiana macrophylla and Lycium bark, soaking them in ethanol solution, performing ultrasonic-assisted extraction, filtering, and obtaining filtrate three; The filtrate 1, filtrate 2, extract and filtrate 3 are combined, heated and concentrated, and the Artemisia annua volatile oil is added to obtain the traditional Chinese medicine preparation.

8. The preparation method according to claim 7, characterized in that: The Artemisia annua is soaked in water for 0.5 to 24 hours; The raw gypsum is soaked in water for 0.5 to 48 hours and boiled in water for 0.5 to 2 hours; The isatis root, kudzu root, scutellaria root, bupleurum root and liquorice are soaked in water for 0.1 to 48 hours and decocted in water for 0.5 to 1 hour; The gardenia and forsythia are soaked in an ethanol solution for 0.1 to 24 hours; The gentiana macrophylla and the cortex lycii are soaked in the ethanol solution for 0.1 to 24 hours.

9. The preparation method according to claim 7, characterized in that: The percolation extraction uses an ethanol solution with a volume concentration of 30% to 70%.

10. The preparation method according to claim 7, characterized in that: The frequency of the ultrasonic-assisted extraction is 20 kHz to 50 kHz, and the extraction time is 0.5 to 2 hours.

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