A traditional Chinese medicine preparation for treating infantile cold and its preparation method

Abstract

The present invention relates to a traditional Chinese medicine preparation for treating infantile cold and its preparation method. The traditional Chinese medicine preparation comprises raw medicinal materials in the following parts by weight: 400-450 parts of honeysuckle, 400-450 parts of forsythia, 400-450 parts of dandelion, 600-800 parts of gypsum, 320-380 parts of bitter apricot kernels, 180-240 parts of ephedra, 400-450 parts of bupleurum, 320-380 parts of scutellaria baicalensis, 320-380 parts of anemarrhena asphodeloides, 400-450 parts of cicada slough, 320-380 parts of pogostemon cablin, 320-380 parts of dried tangerine peel, 600-800 parts of hawthorn, 520-580 parts of coix seed, and 400-450 parts of liquorice. The traditional Chinese medicine preparation of the present invention has the effects of clearing heat and detoxifying, clearing the lung and resolving phlegm, calming endogenous wind and stopping convulsion, and strengthening the spleen and protecting the stomach.

Description

Technical Field

[0001] The present invention relates to a traditional Chinese medicine preparation for treating infantile colds and its preparation method, belonging to the field of traditional Chinese medicine. Background Art

[0002] A cold is a pulmonary exogenous disease mainly manifested by clinical symptoms such as fever, aversion to cold, nasal congestion, runny nose, sneezing, cough, etc. in the lung-defense exterior syndrome. It is commonly known as "catching a cold". Its incidence rate ranks first among pediatric diseases. In Western medicine, "acute respiratory tract infection" belongs to the category of this disease. The cold disease occurs throughout the year, especially with a higher incidence rate in winter and spring seasons and when the climate suddenly changes.

[0003] For infants, their viscera are delicate, their forms and qi are not fully developed, they are in a state of immature yin and yang, the morphological structures of their body viscera are not yet mature, and various physiological functions are not yet sound. Their lungs are delicate and insufficient, and their exterior-defending function is not firm. Their adaptability to environmental climate changes and their resistance after being invaded by exogenous pathogenic factors are relatively poor. In addition, they cannot regulate cold and heat on their own, and if parents often take improper care, exogenous pathogenic factors can invade the lung system through either the mouth and nose or the skin and hair, resulting in a cold. The physiological and pathological characteristics of infants are "three excesses and four deficiencies", namely "yang is often in excess, yin is often insufficient; the heart is often in excess, the lungs are often insufficient; the liver is often in excess, the spleen is often insufficient; the kidney is often insufficient." Therefore, symptoms such as accompanied by phlegm, accompanied by food retention, and accompanied by convulsion are prone to occur clinically. Generally, the prognosis of this disease is good, but clinically, it is common for infants to be prone to getting sick, with rapid transmission, being prone to cold and heat, and being prone to deficiency and excess. If the exterior pathogen does not resolve and spreads inward, it can develop into cough (bronchitis), pneumonia with dyspnea (lobar pneumonia, bronchopneumonia, etc.), or the pathogenic toxin spreads inward, resulting in complications such as pathogenic toxin invading the heart (myocardial damage, myocarditis, pericarditis, etc.), endangering life. Therefore, once an infant catches a cold, active treatment is urgently needed.

[0004] The prior art patent document CN103656122A discloses a traditional Chinese medicine for treating exogenous febrile diseases and its preparation method, which is prepared from raw materials including the following parts by weight: isatis root, mint, bupleurum, pinellia ternata, licorice, scutellaria baicalensis, platycodon grandiflorum, dandelion, notopterygium root, artemisia annua, gypsum fibrosum, clematis chinensis, anemarrhena asphodeloides, honeysuckle flower. This traditional Chinese medicine has significant curative effects on patients with fever caused by viral diseases such as upper respiratory tract infection or influenza, or avian influenza or hand, foot and mouth disease or epidemic parotitis diagnosed by Western medicine, and with syndrome differentiation of febrile diseases of the taiyang, shaoyang, and yangming meridians in traditional Chinese medicine.

[0005] At present, there is no specific drug for treating pediatric colds in Western medicine, and clinical treatment mainly focuses on symptomatic treatment. For fever, children aged ≥2 months take oral acetaminophen, and children aged ≥6 months take oral ibuprofen suspension (or suppository). Both of the above belong to non-steroidal anti-inflammatory drugs, which can reduce fever and relieve pain; for those with nasal congestion and runny nose, nasal spray mometasone furoate (hormone) or oxymetazoline hydrochloride nasal drops, etc.; for cough and expectoration, take oral ambroxol, ambroxol hydrochloride oral solution, etc. Although these Western medicines can relieve symptoms, they all have varying degrees of liver and kidney damage, gastrointestinal irritation, causing nosebleeds, dry nasal mucosa, mental and nervous system symptoms, urticaria, allergies and other adverse reactions. In comparison, the treatment of pediatric colds with traditional Chinese medicine can comprehensively consider dispelling pathogenic factors and strengthening healthy qi, with definite curative effects and very few side effects, and is more easily accepted by children and parents. Especially, the dose of traditional Chinese medicine decoction is large, bitter in taste and inconvenient to carry when going out, while traditional Chinese medicine mixture has the advantages of small dosage, good taste, convenient administration, and higher compliance of children taking medicine, thus greatly improving the clinical treatment effect and being deeply favored by parents and children. And among the proprietary Chinese medicines for treating pediatric colds at present, those that can treat the main syndrome and concurrent syndromes are extremely rare, and this invention fills this gap. Summary of the Invention

[0006] The present invention relates to a traditional Chinese medicine preparation for treating pediatric colds and its preparation method. This formula has the effects of clearing heat and detoxifying, clearing the lungs and resolving phlegm, calming endogenous wind and stopping convulsions, and strengthening the spleen and protecting the stomach. It is clinically used for treating pediatric colds safely and effectively. The symptoms include pediatric fever, sore throat, nasal congestion and runny nose, cough with much phlegm, nausea and vomiting, poor appetite, vomiting of sour and rotten food, red tongue, thick and greasy tongue coating, floating and rapid pulse or string-like pulse or purple stagnation of fingerprint, etc., which belong to the syndrome of exogenous pathogenic factors attacking the lungs combined with spleen deficiency and damp stagnation, with phlegm retention, convulsion, and food retention syndromes. The name of the in-hospital preparation corresponding to the traditional Chinese medicine preparation of the present invention is: Pediatric Detoxifying and Lung-Clearing Mixture. The traditional Chinese medicine preparation of the present invention has the advantages of better compliance of children in clinical application, convenient administration, definite curative effect, and very few side effects. Therefore, it has good industrial application prospects.

[0007] The traditional Chinese medicine formula for treating pediatric colds in the present invention is optimized and selected from multiple classic traditional Chinese medicine formulas under the guidance of the basic theory of traditional Chinese medicine, and is continuously optimized, corrected, summarized, and sorted based on the clinical efficacy feedback. It has good curative effects on the clinical manifestations of pediatric colds such as fever, aversion to cold, nasal congestion and runny nose, cough with much phlegm, poor appetite, vomiting of sour and rotten food, and restless sleep.

[0008] The etiological factors and pathogenesis targeted by this formula are as follows: Six exogenous pathogenic factors invade the body of children. Wind pathogen is the main cause. It combines with the qi of the current season in different seasons to attack people, or due to sudden climate changes, abnormal cold and heat, inappropriate clothing, sweating and being exposed to wind, etc., which causes exogenous pathogens to invade, and the lung fails to clear and disperse, resulting in this disease. The external cause is mainly attributed to being affected by wind pathogen, accompanied by six exogenous pathogenic factors such as cold, heat, dampness, dryness pathogens, or seasonal epidemic poisons. The internal cause is attributed to the deficiency of healthy qi in children or the presence of internal heat, and encountering inducements such as sudden climate changes, imbalance of cold and warmth, sweating and being exposed to wind, improper care, etc. The disease location is in the lung and defensive qi. The pathogenesis is that exogenous pathogens attack the exterior, the defensive yang is checked, and the lung and defensive qi fail to disperse. Because children are prone to getting sick and the disease can spread rapidly, it can involve the heart, liver, and spleen, presenting concurrent syndromes. When the lung is invaded by pathogens, it fails to disperse and descend, the qi movement is unfavorable, and body fluids accumulate to form phlegm. The phlegm congests the airway, then the cough intensifies, the cough sound is heavy and turbid, and there is gurgling sound in the throat, which is a cold with phlegm; the child's disease affects the mother-organ, or due to improper diet, the spleen and stomach are disharmonious, the milk and food accumulate and do not transform, blocking the middle jiao, then there are accompanied by abdominal distension, loss of appetite for milk and food, vomiting of sour and rotten substances, which is a cold with food retention; children are timid and the liver qi is not yet full. After the lung and defensive qi are invaded by pathogens, metal restrains the heart fire or metal restrains the liver wood, the heat disturbs the heart and liver, easily leading to restlessness, startle and crying, restless sleep, and even convulsions and twitching, with a red tip of the tongue, which is a cold with convulsion.

[0009] The syndrome types of the traditional Chinese medicine formula of the present invention for treating children's cold are exogenous pathogen attacking the lung with concurrent phlegm, concurrent convulsion, and concurrent food retention syndromes. This formula is optimized by combining and modifying many famous formulas such as "Five-Ingredient Disinfection Drink", "Maxing Shigan Decoction", "White Tiger Decoction", and "Minor Bupleurum Decoction" from traditional Chinese medicine classics. The inventor of this application, Deputy Chief Physician Xie Xiaoli, combined with years of clinical diagnosis and treatment experience in pediatrics and summarized it based on the feedback of clinical efficacy. In the formula, Flos Lonicerae, Fructus Forsythiae, and Herba Taraxaci are taken from "Five-Ingredient Disinfection Drink" in "Golden Mirror of the Medical Tradition" with the meaning of the same kind assisting each other and the same qi seeking each other, concentrating the superior medicinal power to clear heat and detoxify, cool the blood and reduce swelling, penetrate heat to reach the exterior, and using the methods of clearing and reducing together, and they are used as the monarch drugs together. In the formula, "Maxing Shigan Decoction" and "White Tiger Decoction" in "Treatise on Febrile Diseases" together achieve the effects of dispersing the lung and relieving the exterior, clearing and discharging interior heat, relieving cough and calming asthma, nourishing yin and moistening dryness, promoting the production of body fluids and relieving vexation and thirst, and Gypsum Fibrosum and Rhizoma Anemarrhenae are used together to clear heat without damaging yin; Bupleurum chinense and Scutellaria baicalensis clear the heat in the half-exterior and half-interior. Cicada slough clears heat and relieves sore throat, and stops wind and relieves convulsion. The above are used as the ministerial drugs together. Agastache rugosa is used as an adjuvant to aromatically transform dampness and harmonize the stomach to stop vomiting; Pericarpium Citri Reticulatae regulates qi and strengthens the spleen, dries dampness and resolves phlegm; Semen Coicis stir-fried, strengthens the spleen and removes dampness and stops diarrhea, and also clears the heat of the lung and intestine; Fructus Crataegi prepared with vinegar is sour, sweet and slightly warm, and is especially good at promoting digestion and strengthening the stomach, resolving food retention and stopping diarrhea, and is an important drug for treating greasy meat food retention. Licorice root is used as the guiding drug, tonifying qi and strengthening the spleen, resolving phlegm and relieving cough, clearing heat and detoxifying, and harmonizing all the drugs. Using medicine is like using troops. The combination of various formulas and drugs is like arranging troops in battle formation, each in its proper place and performing its own duties, taking into account both the main syndrome and the concurrent syndromes, and together achieving the effects of clearing heat and detoxifying, clearing the lung and resolving phlegm, stopping wind and relieving convulsion, strengthening the spleen and protecting the stomach, and removing dampness and resolving food retention.

[0010] The dosage of the formula and the dosage ratio of the traditional Chinese medicine preparation of the present invention are obtained by extensive exploration and summary by the inventor of this application in clinical practice, and it has good clinical efficacy within the following weight part ranges for the dosage of each formula.

[0011] The technical solution of this invention patent is as follows:

[0012] A traditional Chinese medicine preparation for treating pediatric colds, the traditional Chinese medicine preparation comprising raw medicinal materials in the following weight proportion: 400-450 parts of honeysuckle, 400-450 parts of forsythia, 400-450 parts of dandelion, 600-800 parts of gypsum, 320-380 parts of bitter apricot kernels, 180-240 parts of ephedra, 400-450 parts of bupleurum, 320-380 parts of scutellaria baicalensis, 320-380 parts of anemarrhena asphodeloides, 400-450 parts of cicada slough, 320-380 parts of pogostemon cablin, 320-380 parts of dried tangerine peel, 600-800 parts of hawthorn, 520-580 parts of coix seed, 400-450 parts of liquorice.

[0013] As a preference of the present invention, the traditional Chinese medicine preparation comprises raw medicinal materials in the following weight proportion: 420 parts of honeysuckle, 420 parts of forsythia, 420 parts of dandelion, 700 parts of gypsum, 350 parts of bitter apricot kernels, 210 parts of ephedra, 420 parts of bupleurum, 350 parts of scutellaria baicalensis, 350 parts of anemarrhena asphodeloides, 420 parts of cicada slough, 350 parts of pogostemon cablin, 350 parts of dried tangerine peel, 700 parts of hawthorn, 560 parts of coix seed, 420 parts of liquorice.

[0014] Preferably, the traditional Chinese medicine preparation comprises raw medicinal materials in the following weight proportion: 450 parts of honeysuckle, 400 parts of forsythia, 450 parts of dandelion, 600 parts of gypsum, 380 parts of bitter apricot kernels, 240 parts of ephedra, 400 parts of bupleurum, 320 parts of scutellaria baicalensis, 380 parts of anemarrhena asphodeloides, 450 parts of cicada slough, 380 parts of pogostemon cablin, 320 parts of dried tangerine peel, 800 parts of hawthorn, 520 parts of coix seed, 400 parts of liquorice.

[0015] Preferably, the traditional Chinese medicine preparation comprises raw medicinal materials in the following weight proportion: 400 parts of honeysuckle, 450 parts of forsythia, 400 parts of dandelion, 800 parts of gypsum, 320 parts of bitter apricot kernels, 180 parts of ephedra, 450 parts of bupleurum, 380 parts of scutellaria baicalensis, 320 parts of anemarrhena asphodeloides, 400 parts of cicada slough, 320 parts of pogostemon cablin, 380 parts of dried tangerine peel, 600 parts of hawthorn, 580 parts of coix seed, 450 parts of liquorice.

[0016] As a further preference of the traditional Chinese medicine preparation of the present invention, the preparation method comprises the following steps:

[0017] Step : Take the above-mentioned honeysuckle, forsythia, dandelion, gypsum, bitter apricot kernels, ephedra, bupleurum, scutellaria baicalensis, anemarrhena asphodeloides, cicada slough, pogostemon cablin, dried tangerine peel, hawthorn, coix seed, liquorice medicinal materials, add 7-12 times the amount of water by weight of the medicinal materials, decoct for 1-3 times, each decoction time is 0.5-2 hours, filter, and combine the above-mentioned decoction filtrates;

[0018] Step : Take the step Combine the decoction filtrates, concentrate and dry them into a clear extract, and then add excipients commonly used in pharmacy to prepare an oral preparation.

[0019] Preferably, in the step , add 10 times the weight of the medicinal materials in water, decoct twice, and the decoction time for each time is 1 hour.

[0020] Preferably, the oral preparation in the step is: oral liquid, granule, pill and other oral preparations.

[0021] Preferably, the application of the traditional Chinese medicine preparation in the preparation of drugs for treating acute upper respiratory tract infection, cough, fever, nasal congestion or runny nose.

[0022] In order to obtain a scientific and reasonable preparation process route of the traditional Chinese medicine preparation of the present invention, a large number of preliminary studies were carried out, and some experimental data were provided to prove the innovation brought by the technical solution of the present invention. The specific scheme is as follows:

[0023] I. Screening of process conditions

[0024] 1. Instruments and reagents

[0025] Waters UPLC H-CLSS ultra-high performance liquid chromatograph, PDA ultraviolet-visible detector, Empower chemical workstation, ACQUITY UPLC BEH C18 column (50mm×2.1mm, 1.7µm), ultrasonic cleaner (H66025T), BP211D analytical balance (Sartorius, Germany), WS70-1 infrared rapid drying oven (manufactured by Shanghai Wusong Hardware Factory), FW135 crusher (Tianjin Test Instrument Co., Ltd.), 101 type electrothermal blast drying oven (Beijing Yongguang Medical Instrument Factory), HCTP11B10 tray pharmaceutical balance (Beijing Xuanwu District Balance Factory). Methanol and acetonitrile are chromatographically pure, water is pure water, and other reagents are all analytically pure. Baicalin reference substance (for content determination, batch number 110715-202223), purchased from the National Institutes for Food and Drug Control.

[0026] 2. Screening of extraction process

[0027] 2.1 Experimental design

[0028] From the data analysis, it can be seen that decocting fifteen herbs, namely honeysuckle, forsythia, dandelion, gypsum, bitter apricot kernel, ephedra, bupleurum, scutellaria baicalensis, anemarrhena asphodeloides, cicada slough, pogostemon cablin, dried tangerine peel, stir-fried hawthorn, stir-fried coix seed, and liquorice tablets, is beneficial to the dissolution of active ingredients, does not increase production costs, and meets the preparation requirements of the mixture dosage form. Therefore, we designed it for decoction. Through orthogonal experiments, with the content of baicalin in scutellaria baicalensis as the inspection index and combined with the amount of dry extract, the extraction times, water addition amount, and extraction time were mainly investigated to determine the optimal water extraction process conditions.

[0029] 2.2 Determination of factor levels and selection of orthogonal array

[0030] In order to determine the optimal extraction conditions, orthogonal experiments were proposed to optimize the conditions involved in the water extraction process. Usually, the extraction time, water addition amount, and extraction times have a greater impact on the extraction results. Therefore, the water addition amount (A), extraction time (B), and extraction times (C) were used as influencing factors, and three levels were selected for each. The L9(34) table was used to arrange the experiments to screen the optimal extraction process conditions. The factor level table is shown in Table 1.

[0031] Table 1 Factor level table

[0032]

[0033] 2.3. Experimental method

[0034] Weigh 9 g of honeysuckle, 9 g of forsythia, 9 g of dandelion, 15 g of gypsum, 7.5 g of bitter apricot kernel, 4.5 g of ephedra, 9 g of bupleurum, 7.5 g of scutellaria baicalensis, 7.5 g of anemarrhena asphodeloides, 9 g of cicada slough, 7.5 g of pogostemon cablin, 7.5 g of dried tangerine peel, 15 g of stir-fried hawthorn, 12 g of stir-fried coix seed, and 9 g of liquorice tablets according to the prescription ratio, and randomly number them from ① to ⑨. Arrange the experiments according to the L9(34) orthogonal array (see Table 3). Filter the extraction solution, measure the total volume, and reserve it for later use.

[0035] 2.4. Preparation of dry extract

[0036] Precisely measure 50 mL of each of the above extraction solutions, place them in pre-weighed evaporating dishes respectively, evaporate to dryness in a water bath, dry the residue at 105 °C for 3 hours, take it out, place it in a desiccator for 30 minutes, weigh and calculate. The results are shown in Table 2.

[0037] 2.5. Determination of baicalin content

[0038] Determine it with reference to the method for determining the content of baicalin under Scutellaria Baicalensis Georgi in Part I of Chinese Pharmacopoeia 2020 Edition.

[0039] Chromatographic conditions Chromatographic column: ACQUITY UPLC BEH C18 column (50 mm × 2.1 mm, 1.7 µm); Mobile phase: methanol - 0.1% phosphoric acid solution (47:53); Flow rate: 0.3 mL / min; Column temperature: room temperature; Detection wavelength: 280 nm; Injection volume: 1.0 μL for reference substance and 0.5 μL for sample.

[0040] Preparation of reference substance solution Weigh an appropriate amount of baicalin reference substance accurately, dissolve it in methanol to make a solution containing 0.2680 mg per 1 mL, and that's it.

[0041] Preparation of test solution Take the water extract obtained from each orthogonal experiment, centrifuge (3500 r, 20 min), draw the supernatant, and filter it through a microporous membrane (0.22 µm), and that's it.

[0042] Determination of sample content According to General Principles 0512 of the Chinese Pharmacopoeia 2020 Edition, accurately draw 1.0 μL of the reference substance solution and 0.5 μL of each test solution respectively, inject them into the liquid chromatograph for determination, and the results are shown in Table 2.

[0043] Table 2 Orthogonal experiment table of water extraction L9(34)

[0044]

[0045]

[0046] Comprehensive value = (amount of baicalin / maximum amount of baicalin) * 70 + (amount of dry extract / maximum amount of dry extract) * 30

[0047] 2.6. Analysis of variance

[0048] According to the data in the orthogonal experiment arrangement and data analysis in Table 2, perform analysis of variance, and the results are shown in Table 3 below.

[0049] Table 3 Analysis of variance table

[0050]

[0051] The magnitude of the range R value in Table 2 shows that the primary and secondary effects of each factor are C > A > B, and factors A, B, and C in the analysis of variance (Table 3) have no significant effects. Considering comprehensively, the optimal process combination is determined as A2B1C2. That is, add 10 times the amount of water, decoct 2 times, each time for 1.0 hour.

[0052] 2.7. Verification test

[0053] Weigh the medicinal materials according to the prescription ratio, and conduct a verification test according to the optimized process conditions, and the results are shown in Table 4.

[0054] Table 4 Results of verification test

[0055]

[0056] Table 4 shows that both the amount of baicalin and the amount of dry extract are relatively stable from the verification results, indicating that the optimized extraction conditions are basically feasible.

[0057] 3 Forming process of the preparation

[0058] (1) Concentration

[0059] This product is a mixture. The extracted solution is concentrated to meet the volume requirements.

[0060] (2) Selection of preservative

[0061] The mixture belongs to the solution. We choose conventional ethylparaben as the preservative for this product. Its dosage is set at 0.5 g per liter according to relevant regulations.

[0062] (3) Selection of flavoring agent

[0063] This product is for pediatric use and does not involve the situation of sugar prohibition. Therefore, sucrose powder, which is cheap, easy to obtain and has a relatively mild taste, is selected as the flavoring agent for this product. Different proportions of sucrose powder are added to the concentrated solution and the taste is tasted. The results are shown in Table 5.

[0064] Table 5 Comparison results of the taste with different dosages of sucrose powder

[0065]

[0066] It can be seen from the results in Table 5 that when the mixture is prepared at the ratio of concentrated solution: sucrose powder = 100:15, the sweetness is appropriate and the taste is good.

[0067] IV. Pilot study

[0068] 1. Pilot process

[0069] The above fifteen herbs are decocted twice with 10 times the amount of water for 1.0 hour each time, filtered, the filtrates are combined, concentrated to an appropriate amount, mixed with 150 g of sucrose powder and 0.5 g of ethylparaben, and adjusted with water to make 1000 ml, thus obtaining the product.

[0070] 2. Pilot production data

[0071] According to the above preparation process, three batches of pilot scale-up tests are carried out. The total feeding amount of each batch is 10 times, 10 times, and 10 times the amount of the 1000 ml finished product prescription respectively. Three batches of pilot products are prepared, and the batch numbers are 20221201, 20221202, and 20221203 respectively. The test data and intermediate parameters are shown in Table 6.

[0072] Table 6 Test results of three batches of pilot tests

[0073]

[0074] Beneficial effects of the traditional Chinese medicine preparation of the present invention

[0075] The prescription of the present invention is prepared by optimizing and selecting from many classical famous prescriptions such as the traditional Chinese medicine classical prescription "Five-Ingredient Detoxifying Drink", "Maxing Shigan Decoction", "White Tiger Decoction", "Minor Bupleurum Decoction", etc., and combining with the clinical practice experience of the inventors of the present application for many years. According to the clinical efficacy feedback, it is continuously optimized, corrected, summarized and sorted out. This prescription is composed of honeysuckle, forsythia, dandelion, ephedra, apricot kernel, gypsum, anemarrhena, bupleurum, scutellaria, ageratum, tangerine peel, stir-fried hawthorn, stir-fried coix seed, and licorice. The monarch, minister, assistant and envoy of the whole prescription are reasonably combined to achieve the effects of clearing heat and detoxifying, clearing the lungs and resolving phlegm, calming endogenous wind and stopping convulsions, strengthening the spleen and protecting the stomach, and removing dampness and stagnation. It is clinically used for the treatment of pediatric colds and their concurrent syndromes safely and effectively.

[0076] Dosage form advantages: The prescription of the present invention (the corresponding name of the hospital preparation is: Pediatric Detoxifying and Lung-Clearing Mixture)

[0077] It can be used to treat upper respiratory tract infections, influenza, acute bronchitis, mild pneumonia, etc. The symptoms include fever, sore throat, nasal congestion, runny nose, cough with excessive phlegm, nausea and vomiting, loss of appetite, abdominal pain and diarrhea, red tongue, thick and greasy tongue coating, floating and rapid pulse or string-like pulse or purple stagnation of fingerprint, etc., which belong to the syndrome of exogenous pathogenic factors attacking the lungs and concurrent spleen deficiency and dampness stagnation. This prescription was originally used in the form of decoction, but the decoction needs to be freshly prepared, is prone to mildew after long-term storage, is inconvenient to carry, and the oral dosage is also large, which is difficult to meet the requirements of modern preparations such as definite curative effect, controllable quality, convenient production, and convenient clinical medication. The mixture not only maintains the rapid effect of the decoction, but also overcomes the disadvantage of inconvenient decoction when used clinically; moreover, it is small in volume, convenient for taking, storing and transporting. In addition, compared with dosage forms such as traditional Chinese medicine capsules, tablets, and oral liquids, the mixture usually does not require too much refining treatment of the medicinal material extract, which is particularly suitable for traditional Chinese medicine compound preparations with not very clear active ingredients. Therefore, this product selects the mixture as the dosage form of this product.

[0078] The preparation process of the traditional Chinese medicine preparation of the present invention is scientific and reasonable. According to the requirements of traditional Chinese medicine theory and clinical medication, we analyze the functions of each medicine in the prescription, and focus on considering the physicochemical properties, pharmacological effects of the active ingredients contained in each medicine, and the needs of the preparation forming process, and determine the preparation process design of this preparation as: Fifteen kinds of medicinal materials, including honeysuckle, forsythia, dandelion, gypsum, bitter apricot kernel, ephedra, bupleurum, scutellaria, anemarrhena, cicada slough, ageratum, tangerine peel, stir-fried hawthorn, stir-fried coix seed, and licorice tablets, are decocted with water, the decocted liquid is combined, allowed to stand, and the supernatant is concentrated to an appropriate amount; among them, 10 times the weight of water of the medicinal materials is added, and decocted 2 times, with each decoction time being 1 hour. Sucrose powder and ethyl p-hydroxybenzoate are added and the total amount is adjusted.

[0079] After years of repeated clinical application and verification, the total clinical effective rate of the traditional Chinese medicine preparation of the present invention is as high as 100%. The traditional Chinese medicine preparation of the present invention has the advantages of remarkable clinical curative effect and safety and convenience in the treatment of children's colds, and is worthy of popularization and application in clinical practice. Description of the Drawings

[0080] The drawings described herein are used to provide a further understanding of the present invention and constitute a part of the present invention. The schematic embodiments of the present invention and their descriptions are used to explain the present invention and do not constitute an improper limitation of the present invention.

[0081] Figure 1 It is the thin-layer identification chromatogram of Forsythia suspensa (from left to right in sequence: Samples 1-3, batch numbers: 20221201, 20221202, 20221203, 4-phillyrin reference substance, 5-phillyrin reference substance, 6-negative control sample);

[0082] Figure 2 It is the thin-layer identification chromatogram of Citrus reticulata Blanco (from left to right in sequence: Samples 1-3, batch numbers: 20221201, 20221202, 20221203, 4-hesperidin reference substance, reference medicinal material, 5-negative control sample);

[0083] Figure 3 It is the thin-layer identification chromatogram of Scutellaria baicalensis Georgi (from left to right in sequence: Samples 1-3, batch numbers: 20221201, 20221202, 20221203, 4-baicalin reference substance, 5-baicalin reference substance, 6-negative control sample);

[0084] Figure 4 It is the thin-layer identification chromatogram of Ephedra sinica Stapf (from left to right in sequence: Samples 1-3, batch numbers: 20221201, 20221202, 20221203, 4-ephedrine hydrochloride reference substance, 5-negative control sample);

[0085] Figure 5 It is the thin-layer identification chromatogram of Taraxacum mongolicum Hand.-Mazz. (from left to right in sequence: Samples 1-3, batch numbers: 20221201, 20221202, 20221203, 4-chicoric acid reference substance, reference medicinal material of Taraxacum mongolicum Hand.-Mazz., 6-negative control sample);

[0086] Figure 6 It is the thin-layer identification chromatogram of Lonicera japonica Thunb. (from left to right in sequence: Samples 1-3, batch numbers: 20221201, 20221202, 20221203, 4-chlorogenic acid reference substance, 5-negative control sample);

[0087] Figure 7Thin-layer identification chromatogram of Hawthorn Fruit (Samples 1 - 3, batch numbers: 20221201, 20221202, 20221203, 4. Control crude drug of Hawthorn Fruit, 5. Ursolic acid reference substance, 6. Negative control sample);

[0088] Figure 8 Thin-layer identification chromatogram of Bupleurum Root (daylight) (Samples 1 - 3, batch numbers: 20221201, 20221202, 20221203, 4. Control crude drug of Bupleurum Root, 5. Negative control sample);

[0089] Figure 9 Thin-layer identification chromatogram of Bupleurum Root (fluorescence) (Samples 1 - 3, batch numbers: 20221201, 20221202, 20221203, 4. Control crude drug of Bupleurum Root, 5. Negative control sample);

[0090] Figure 10 Thin-layer identification chromatogram of Anemarrhena Rhizome (Samples 1 - 3, batch numbers: 20221201, 20221202, 20221203, 4. Control crude drug of Anemarrhena Rhizome, 5. Mangiferin reference substance, 6. Negative control sample). Detailed implementation mode

[0091] To more fully understand the implementation of the present invention, one or more experimental examples are listed below, and the present invention is further described through typical examples. (The dosage forms of the traditional Chinese medicine preparation of the present invention include, but are not limited to, decoction, mixture, formula granules, pills, etc.)

[0092] Example 1 Preparation of the mixture of the traditional Chinese medicine preparation of the present invention

[0093] Take 420 g of Flos Lonicerae, 420 g of Fructus Forsythiae, 420 g of Herba Taraxaci, 700 g of Gypsum Fibrosum (decocted first), 350 g of Semen Armeniacae Amarum, 210 g of Herba Ephedrae, 420 g of Radix Bupleuri, 350 g of Radix Scutellariae, 350 g of Rhizoma Anemarrhenae, 420 g of Periostracum Cicadae, 350 g of Herba Pogostemonis (decocted later), 350 g of Pericarpium Citri Reticulatae, 700 g of Fructus Crataegi Praeparatus, 560 g of Semen Coicis Parched, 420 g of Radix Glycyrrhizae; for the above fifteen herbs, decoct with 10 times the amount of water twice, each time for 1.0 hour, filter, combine the filtrates, concentrate to an appropriate amount, add 150 g of sucrose powder and 0.5 g of ethylparaben, mix well, and adjust the volume to 1000 ml with water to obtain the mixture.

[0094] Example 2 Preparation of the mixture of the traditional Chinese medicine preparation of the present invention

[0095] Take 450 g of Flos Lonicerae, 400 g of Fructus Forsythiae, 450 g of Herba Taraxaci, 600 g of Gypsum Fibrosum (decocted first), 380 g of Semen Armeniacae Amarum, 240 g of Herba Ephedrae, 400 g of Radix Bupleuri, 320 g of Radix Scutellariae, 380 g of Rhizoma Anemarrhenae, 450 g of Periostracum Cicadae, 380 g of Herba Pogostemonis (decocted later), 320 g of Pericarpium Citri Reticulatae, 800 g of Fructus Crataegi Praeparatus, 520 g of Semen Coicis Parched, 400 g of Radix Glycyrrhizae; The above fifteen herbs are respectively added with 12 times the amount of water, decocted once for 1.0 hour each time, filtered, the filtrates are combined, concentrated to an appropriate amount, 60 g of Stevioside and 0.6 g of Sodium Benzoate are added and mixed evenly, and the volume is adjusted to 1000 ml with water to obtain the product.

[0096] Example 3 Preparation of the traditional Chinese medicine preparation mixture of the present invention

[0097] Take 400 g of Flos Lonicerae, 450 g of Fructus Forsythiae, 400 g of Herba Taraxaci, 800 g of Gypsum Fibrosum (decocted first), 320 g of Semen Armeniacae Amarum, 180 g of Herba Ephedrae, 450 g of Radix Bupleuri, 380 g of Radix Scutellariae, 320 g of Rhizoma Anemarrhenae, 400 g of Periostracum Cicadae, 320 g of Herba Pogostemonis (decocted later), 380 g of Pericarpium Citri Reticulatae, 600 g of Fructus Crataegi, 580 g of Semen Coicis, 450 g of Radix Glycyrrhizae; The above fifteen herbs are respectively added with 7 times the amount of water, decocted three times for 0.5 hour each time, filtered, the filtrates are combined, concentrated to an appropriate amount, 80 g of Xylitol and 0.8 g of Sorbic Acid are added and mixed evenly, and the volume is adjusted to 1000 ml with water to obtain the product.

[0098] Example 4 Preparation of the traditional Chinese medicine preparation granule of the present invention

[0099] Take 420 g of Flos Lonicerae, 420 g of Fructus Forsythiae, 420 g of Herba Taraxaci, 700 g of Gypsum Fibrosum (decocted first), 350 g of Semen Armeniacae Amarum, 210 g of Herba Ephedrae, 420 g of Radix Bupleuri, 350 g of Radix Scutellariae, 350 g of Rhizoma Anemarrhenae, 420 g of Periostracum Cicadae, 350 g of Herba Pogostemonis (decocted later), 350 g of Pericarpium Citri Reticulatae, 700 g of Fructus Crataegi Praeparatus, 560 g of Semen Coicis Parched, 420 g of Radix Glycyrrhizae; The above fifteen herbs are respectively added with 10 times the amount of water, decocted twice for 1.0 hour each time, filtered, the filtrates are combined, concentrated under reduced pressure, the drying temperature is 56 °C - 63 °C, the vacuum degree is -0.07 - -0.09 Mpa, dried into dry extract powder, and then starch and dextrin are added to make granules.

[0100] Example 5 Preparation of the traditional Chinese medicine preparation pill of the present invention

[0101] Take 420g of honeysuckle, 420g of forsythia, 420g of dandelion, 700g of gypsum (fried first), 350g of bitter almond, 210g of ephedra, 420g of bupleurum, 350g of scutellaria, 350g of anemarrhena, 420g of cicada molt, 350g of patchouli (added later), 350g of tangerine peel, 700g of charred hawthorn, 560g of stir-fried coix seed, and 420g of raw licorice; decoct the above 15 ingredients twice with 10 times the amount of water, each time for 1.0 hour, filter, combine the filtrate, and concentrate under reduced pressure, the drying temperature is 55℃~65℃, the vacuum degree is -0.06~-0.10Mpa, dry into dry paste powder, add honey adhesive and appropriate amount of water, mix well, and make into pills.

[0102] Example 6 Internal Control Quality Standards of the Traditional Chinese Medicine Preparation of the Present Invention

[0103] 6.1 Instruments, reagents and test drugs:

[0104] Ultrasonic cleaning machine (H66025T), BP211D analytical balance (Sartorius, Germany), WS70-1 infrared rapid drying oven (manufactured by Shanghai Wusong Hardware Factory), FW135 crusher (Tianjin Test Instrument Co., Ltd.), four-hole water bath (Beijing Kewei Yongxing Instrument Co., Ltd.), three-purpose UV analyzer (Shanghai Jingke Industrial Co., Ltd., WFH-201B UV transmission and reflection instrument). 101 electric heating blast drying oven (Beijing Yongguangming Medical Instrument Factory), double-slot chromatography cylinder (specifications 200 mm×200 mm).

[0105] Reference substances and reference medicinal materials: Forsythiaside (batch number 110821-201514, purity ≥98%), China Food and Drug Inspection Institute, Hesperidin (batch number 110721-201818, purity ≥98%), China Food and Drug Inspection Institute, Baicalin (batch number 110715-201318, purity ≥98%), China Food and Drug Inspection Institute, Chicoric acid (batch number Y02J12Y136139, purity ≥98%), Shanghai Yuanye Biotechnology Co., Ltd., Dandelion (batch number 121195-202004), China Food and Drug Inspection Institute, Ephedrine Hydrochloride (batch number 171241-201809, purity ≥98%), China Food and Drug Inspection Institute, Chlorogenic acid (batch number MUST- 18030620, purity ≥98%), Chengdu Mansite Biotechnology Co., Ltd., Crataegus pinnatifida (batch number 121626-201402), China Food and Drug Inspection Institutes, Ursolic acid (batch number wkq20061211, purity ≥98%), Sichuan Weikeqi Biotechnology Co., Ltd., Bupleurum chinense (batch number 120992-201509), China Food and Drug Inspection Institutes, Anemarrhena asphodeloides (batch number 121070-201806), China Food and Drug Inspection Institutes.

[0106] 6.2 All other reagents are of analytical grade.

[0107] Silica gel G (Qingdao Ocean Chemical Industry Co., Ltd.). The samples used in this item were provided by the Preparation Room of Shaanxi Provincial Hospital of Traditional Chinese Medicine, with batch numbers (20221201, 20221202, 20221203).

[0108] Appearance: This product is a dark brown liquid; sweet and slightly bitter in taste.

[0109] Thin-layer identification:

[0110] (1) Identification of Forsythia suspensa: Take 10 ml of this product, add 40 ml of methanol, ultrasonically treat for 20 minutes, filter, evaporate the filtrate to dryness, dissolve the residue in 20 ml of 0.2% sodium hydroxide solution, heat to dissolve, extract with water-saturated n-butanol twice, 30 ml each time, combine the n-butanol solutions, evaporate to dryness, dissolve the residue in 20 ml of 0.2% sodium hydroxide solution, heat to dissolve, extract with chloroform twice, 30 ml each time, combine the chloroform solutions, evaporate to dryness, dissolve the residue in 1 ml of methanol to obtain the test solution. Separately take phillyrin reference substance, add methanol to make a solution containing 1 mg per 1 ml as the reference solution. Run a blank in parallel. According to the thin-layer chromatography method (General Rules 0502, Volume IV, Chinese Pharmacopoeia 2020 Edition), take 10 μl of the test solution and 5 μl of the reference solution, respectively spot them on the same silica gel G thin-layer plate, use chloroform-methanol-formic acid (9:1:0.1) as the developing solvent, develop, take out, dry in air, spray with 2% vanillin sulfuric acid solution, heat at 105 °C until the spots are clearly visible. In the chromatogram of the test solution, at the corresponding position to the chromatogram of the reference substance, there are spots showing the same color. The blank has no interference, so it is included in the standard text (see the appendix of the instruction manual Figure 1 )

[0111] (2) Identification of Tangerine Peel: Take 10 ml of this product, add 40 ml of methanol, ultrasonically treat for 20 minutes, filter, evaporate the filtrate to dryness, dissolve the residue in 20 ml of water, extract with water-saturated n-butanol twice, 20 ml each time, combine the n-butanol solutions, evaporate to dryness, dissolve the residue in 1 ml of methanol to obtain the test solution. Separately take hesperidin reference substance, prepare a solution containing 1 mg per 1 ml with methanol as the reference solution. Run a blank sample in parallel. According to the thin-layer chromatography method (General Principles 0502, Volume IV of Chinese Pharmacopoeia 2020 Edition), absorb 5 μl of each of the above two solutions, respectively spot them on the same silica gel G thin-layer plate prepared with 1% sodium hydroxide solution, use ethyl acetate - methanol - water (100:17:13) as the developing solvent, develop to about 5 cm, take out, air dry, then use the upper layer solution of toluene - ethyl acetate - formic acid - water (20:10:1:1) as the developing solvent, develop to about 8 cm, take out, air dry, spray with 2% aluminum trichloride ethanol solution, and examine under ultraviolet light (365 nm). In the chromatogram of the test sample, at the position corresponding to the chromatogram of the reference substance, fluorescent spots of the same color appear. The blank has no interference, so it is included in the standard text (see Appendix of the Instructions Figure 2 ).

[0112] (3) Identification of Scutellaria Root: Take 10 ml of this product, add 40 ml of ethanol, ultrasonically treat for 20 minutes, filter, evaporate the filtrate to dryness, dissolve the residue in 20 ml of water, adjust the pH value to 2 - 3 with hydrochloric acid, extract with ethyl acetate twice, 20 ml each time, combine the ethyl acetate solutions, evaporate to dryness, dissolve the residue in 1 ml of methanol to obtain the test solution. Separately take an appropriate amount of baicalin reference substance, prepare a solution containing 2 mg per 1 ml with methanol as the reference solution. Run a blank sample in parallel. According to the thin-layer chromatography method (General Principles 0502, Volume IV of Chinese Pharmacopoeia 2020 Edition), absorb 6 - 8 μl of the test solution and 3 μl of the reference solution, respectively spot them on the same silica gel G thin-layer plate using sodium carboxymethylcellulose solution containing 4% sodium acetate as the binder, use ethyl acetate - butanone - formic acid - water (5:3:1:1) as the developing solvent, develop, take out, air dry, and spray with 1% ferric trichloride ethanol solution. In the chromatogram of the test sample, at the position corresponding to the chromatogram of the reference substance, spots of the same color appear. The blank has no interference, so it is included in the standard text (see Appendix of the Instructions Figure 3 ).

[0113] (4) Identification of Ephedra: Take 20 ml of this product, add 2 ml of concentrated ammonia, extract twice with ether, 30 ml each time, combine the ether solution, evaporate to dryness, add 1 ml of dichloromethane to the residue to dissolve it, and use it as the test solution. Take an appropriate amount of ephedrine hydrochloride reference substance, add dichloromethane to make a solution containing 1 mg per 1 ml, as the reference solution. Carry a blank. According to the thin layer chromatography method (General Rules 0502 of Part IV of the 2020 Edition of the Chinese Pharmacopoeia), take 5 μl of each of the above solutions and spot them on the same silica gel G thin layer plate, use chloroform-methanol-concentrated ammonia test solution (20:5:0.5) as the developing solvent, pre-balance for 15 to 30 minutes, develop, take out, and dry. Spray with 0.3% ninhydrin test solution and heat at 105 °C until the spots are clearly colored. In the chromatogram of the test sample, spots of the same color appear at the corresponding position of the chromatogram of the reference substance. Blank space has no interference, so it is included in the standard text (see Appendix of the instruction manual) Figure 4 ).

[0114] (5) Identification of dandelion: Take chicoric acid reference substance, add methanol to make a solution containing 1 mg per 1 ml, as the reference substance solution, take 1 g of dandelion reference medicinal material, add 10 ml of 80% methanol, ultrasonically treat for 20 minutes, filter, and take the filtrate as the reference medicinal material solution. Carrying blank. According to the thin layer chromatography method (General Rules 0502 of Part IV of the 2020 Edition of the Chinese Pharmacopoeia), take 2-3 μl of the above-mentioned reference substance solution and reference medicinal material solution, and 5 μl of the test solution under identification (2), respectively, and spot them on the same silica gel G thin layer plate, use butyl acetate-formic acid-water (7:2.5:2.5) upper layer solution as the developing agent, develop, take out, dry, and examine under ultraviolet light (365nm). In the test sample chromatogram, there is no fluorescent spot of the same color at the corresponding position of the reference sample chromatogram and the reference medicinal material chromatogram, so it is not included in the standard text for the time being (see the appendix of the instruction manual). Figure 5 ).

[0115] (6) Identification of honeysuckle: Take chlorogenic acid reference substance, add methanol to make a solution containing 1 mg per 1 ml, as the reference solution. Carry a blank. According to the thin layer chromatography method (General Rules 0502 of Part IV of the 2020 Edition of the Chinese Pharmacopoeia), take 2 μl of the reference solution and the test solution under identification (2), spot them on the same silica gel G thin layer plate, use the upper layer solution of butyl acetate-formic acid-water (7:2.5:2.5) as the developing agent, develop, take out, dry, and examine under ultraviolet light (365nm). In the chromatogram of the test sample, there is no fluorescent spot of the same color at the corresponding position in the chromatogram of the reference sample, so it is not included in the standard text for the time being (see the appendix of the instruction manual). Figure 6 ).

[0116] (7) Identification of Hawthorn Fruit: Take 5 ml of this product, add 20 ml of ethyl acetate, ultrasonically treat for 20 minutes, filter, evaporate to dryness, and dissolve the residue in 1 ml of methanol. Separately take 1 g of hawthorn fruit medicinal material and prepare a control medicinal material solution in the same way. Then take oleanolic acid reference substance and prepare a solution containing 1 mg per 1 ml with methanol as the reference substance solution. Run a blank sample in parallel. According to the thin-layer chromatography method (General Principles 0502, Volume IV of the Chinese Pharmacopoeia 2020 Edition), take 4 μl of each of the above solutions and spot them on the same silica gel G thin-layer plate respectively. Use toluene - ethyl acetate - formic acid (20∶4∶0.5) as the developing solvent, develop, take out, air dry, spray with 10% sulfuric acid ethanol solution, and heat at 80 °C until the spots are clearly visible. In the chromatogram of the test sample, there are no spots of the same color at the corresponding positions as in the chromatogram of the reference substance. Therefore, it is not included in the standard text for the time being (see the appendix of the instruction manual Figure 7 ).

[0117] (8) Identification of Bupleurum Root: Take 5 ml of this product, add 20 ml of methanol, ultrasonically treat for 20 minutes, filter, and concentrate the filtrate to 1 ml as the test sample solution. Separately take 0.5 g of bupleurum root control medicinal material and prepare a control medicinal material solution in the same way. Run a blank sample in parallel. According to the thin-layer chromatography method (General Principles 0502, Volume IV of the Chinese Pharmacopoeia 2020 Edition), take 2 μl of each of the above solutions and spot them on the same silica gel G thin-layer plate respectively. Use ethyl acetate - ethanol - water (8:2:1) as the developing solvent, develop, take out, air dry, spray with 40% sulfuric acid solution of 2% p-dimethylaminobenzaldehyde, and heat at 60 °C until the spots are clearly visible. Examine under daylight and ultraviolet light (365 nm) respectively. In the chromatogram of the test sample, there are no spots or fluorescent spots of the same color at the corresponding positions as in the chromatogram of the control medicinal material and the reference substance. Therefore, it is not included in the standard text for the time being (see the appendix of the instruction manual Figure 8 , 9 ).

[0118] (9) Identification of Anemarrhena Rhizome: Take 5 ml of this product, add 20 ml of ethanol, ultrasonically treat for 20 minutes, filter, evaporate to dryness, and dissolve the residue in 1 ml of methanol as the test sample solution. Separately take 0.5 g of anemarrhena rhizome medicinal material and prepare a medicinal material control solution in the same way. Then take mangiferin reference substance and prepare a solution containing 0.5 mg per 1 ml with dilute ethanol as the reference substance solution. Run a blank sample in parallel. According to the thin-layer chromatography method (General Principles 0502, Volume IV of the Chinese Pharmacopoeia 2020 Edition), take 4 μl of each of the above solutions and spot them on the same polyamide film respectively. Use ethanol - water (1:1) as the developing solvent, develop, take out, air dry, and examine under ultraviolet light (365 nm). In the chromatogram of the test sample, there are no fluorescent spots of the same color at the corresponding positions as in the chromatogram of the reference substance and the control medicinal material. Therefore, it is not included in the standard text for the time being (see the appendix of the instruction manual Figure 10 ).

[0119] Inspection: In accordance with the relevant requirements under the general rules for mixture in Part IV of the Chinese Pharmacopoeia (2020 Edition), the relative density, pH value, and filling volume of three batches of pilot-scale samples were inspected, and the results are shown in Table 7.

[0120] Table 7 Inspection Results of Three Batches of Pilot-Scale Samples

[0121] Batch number 20221201 20221202 20221203 Relative density (should not be less than 1.05) 1.11 1.11 1.11 pH value (should be 3.5 - 5.5) 4.46 4.44 4.45 Filling volume Meet the requirements Meet the requirements Meet the requirements

[0122] Functions and indications: Clearing heat and detoxifying, clearing the lungs and resolving phlegm, calming endogenous wind and stopping convulsions, strengthening the spleen and protecting the stomach, dispelling dampness and regulating qi stagnation. It is used for the treatment of upper respiratory tract infections, influenza, acute bronchitis, mild pneumonia, etc. Symptoms include fever, sore throat, nasal congestion, runny nose, cough with profuse phlegm, nausea and vomiting, poor appetite, abdominal pain and diarrhea, red tongue, thick and greasy tongue coating, floating and rapid pulse or string-like pulse or purple stagnant fingerprint, etc., which belong to the syndrome of exogenous pathogenic factors attacking the lungs and concurrent spleen deficiency with dampness stagnation.

[0123] 1. Clinical Observation of the Traditional Chinese Medicine Preparation of the Invention in the Treatment of Infantile Cold

[0124] 1.1 General Information

[0125] 198 cases of infantile cold children with the syndrome of exogenous pathogenic factors attacking the lungs and concurrent syndrome were collected from the pediatric outpatient department in line with the clinical standard requirements (Shaanxi Provincial Hospital of Traditional Chinese Medicine). The general information of the children such as age, course of disease, and degree of illness was compared, and there was no statistical significance (P > 0.05), showing comparability.

[0126] 1.2 Diagnostic Criteria

[0127] 1.2.1 Western Medicine Diagnostic Criteria

[0128] Western medicine diagnostic criteria (refer to the 9th Edition of Practical Pediatrics for Children edited by Wang Tianyou et al., People's Medical Publishing House): Acute upper respiratory tract infection; 1) There has been a history of contact with the epidemic of upper respiratory tract infection; 2) Clinical manifestations include fever, sore throat, nasal congestion, runny nose, sneezing, cough with or without phlegm, vomiting, poor appetite, diarrhea, convulsions, etc. 3) Blood picture: In viral infections, the white blood cell count is generally normal or low; in bacterial infections, the total white blood cell count is mostly increased, and it can also be decreased in severe cases.

[0129] 1.2.2 Traditional Chinese Medicine Syndrome Differentiation Criteria

[0130] Traditional Chinese medicine syndrome diagnostic criteria (formulated with reference to the Syndrome Part of the Clinical Diagnosis and Treatment Terminology of Traditional Chinese Medicine GB / T16751.2 - 1997 and the Guiding Principles for Clinical Research of New Traditional Chinese Medicines 2002).

[0131] Syndrome of exogenous pathogenic factors attacking the lungs: Main symptoms: Fever, dry throat, sore throat, cough, nasal congestion, runny nose, red tongue, floating pulse or floating and rapid pulse. Secondary symptoms: Body aches, hoarseness, loss of appetite, vomiting, abdominal pain and diarrhea, poor appetite, red or not red tongue with thin coating.

[0132] 1.3 Inclusion Criteria

[0133] 1) Meeting the diagnostic criteria of acute upper respiratory tract infection in Western medicine; 2) Meeting the diagnostic criteria of exogenous pathogen attacking the lung syndrome with concurrent syndrome of common cold in traditional Chinese medicine; 3) Age: under 18 years old (the scope of pediatric clinic); 4) Voluntarily signing the informed consent form.

[0134] 1.4 Exclusion criteria

[0135] 1) Excluding children with similar symptoms such as sinusitis, diphtheria, acute gastroenteritis, acute appendicitis, etc.;

[0136] 2) Children with allergic constitution or allergic to multiple drugs, or with a history of allergy to the components of the drugs used in this trial; 3) Those who have used other drugs for treating this disease after the onset; 4) Those who have not taken the medicine as prescribed and whose curative effects cannot be judged, or whose data are incomplete and the curative effects cannot be judged.

[0137] 1.5 Treatment method

[0138] Preparation of the experimental drug of the present invention: Take 6g of honeysuckle, 6g of forsythia, 6g of dandelion, 10g of gypsum, 5g of bitter apricot kernels, 3g of raw ephedra, 6g of bupleurum, 5g of scutellaria baicalensis, 5g of anemarrhena asphodeloides, 5g of pogostemon cablin, 5g of dried tangerine peel, 10g of stir-fried hawthorn, 8g of stir-fried coix seed, 6g of raw licorice, add an appropriate amount of water and soak for 30 minutes, boil with strong fire, turn to slow fire and boil for 30 minutes, filter; then add an appropriate amount of water and decoct for 20 minutes, filter; combine the two filtrates to obtain 1 dose of the traditional Chinese medicine decoction of the present invention.

[0139] Dosage and administration:

[0140] Oral administration: For children ≤ 6 months old, 1 dose of the decoction of the present invention can be taken for 4 days; for children aged 7 months - 11 months, 1 dose of the decoction of the present invention can be taken for 3 days; for children aged 1 year - 1 year and 11 months, 1 dose of the decoction of the present invention can be taken for 2 days; for children aged 2 years - 3 years, 1 dose of the decoction of the present invention can be taken for 1 day; for children aged 4 years - 6 years: half of 1 dose of the decoction of the present invention can be taken for 1 day; for those over 7 years old, 2 doses of the traditional Chinese medicine decoction of the present invention can be taken for 1 day. Take it 3 times a day, warm it and take it half to 1 hour after breakfast, lunch and dinner. One course of treatment is 3 days, and continue to take it for 3 days after improvement to consolidate the curative effect.

[0141] Precautions: 1. Avoid eating raw, cold, spicy and greasy foods. 2. It is prohibited for those allergic to this product, and those with allergic constitution should use it with caution. 3. Take it according to the dosage and administration. If the symptoms do not improve after taking it for 3 days or the symptoms worsen during the medication period, seek medical advice in time. 4. Children must be used under the supervision of adults. 5. Please keep this product out of the reach of children. 6. If you are using other drugs, please consult a doctor or pharmacist before using this product.

[0142] 1.6 Curative effect evaluation criteria

[0143] Therapeutic effect index (Nimodipine method) = (score before treatment - score after treatment) / score before treatment × 100%

[0144] Cure: Clinical symptoms disappear or basically disappear, and the syndrome score decreases by ≥ 95%.

[0145] Marked effect: Clinical symptoms are significantly improved, and the syndrome score decreases by ≥ 70%.

[0146] Effective: Clinical symptoms are partially improved, and the syndrome score decreases by ≥ 30%.

[0147] Ineffective: Clinical symptoms are not significantly improved or even worsened, and the syndrome score decreases by less than 30%.

[0148] 1.7 Treatment results

[0149] Group Case Cured Markedly effective Effective Ineffective Total effective rate Treatment group 198 27 149 4 18 90.9%

[0150] Table 8 Comparative results of clinical efficacy observation

[0151] It can be seen from the clinical trial results in Table 8 that the total effective rate of the treatment group of the present invention is 90.9%, and the clinical symptoms of the vast majority of patients have been significantly improved.

[0152]

[0153] Table 9 Improvement of clinical symptoms after treatment with the traditional Chinese medicine preparation of the present invention

[0154] It can be seen from the results in Table 9 that after the patients took the traditional Chinese medicine preparation of the present invention, the symptoms of fever, pharyngeal redness, cough, nasal congestion or runny nose were significantly improved. In particular, the total effective rate of patients with improved fever symptoms was 96.9%, and the patients with improved pharyngeal redness symptoms reached 85.5%.

[0155] 1.8 Adverse reactions

[0156] Moreover, no adverse reactions were found during the clinical treatment observation of the traditional Chinese medicine preparation of the present invention. The above clinical statistical results show that the traditional Chinese medicine preparation of the present invention has significant clinical efficacy in the treatment of exogenous pathogen attacking the lung syndrome and its concurrent syndromes in children with colds, and is safe, convenient to take, and worthy of active promotion and application in pediatric clinical practice.

Claims

1. A traditional Chinese medicine preparation for treating pediatric cold, characterized in that, the traditional Chinese medicine preparation is made from the following raw materials in parts by weight: 400 - 450 parts of honeysuckle flower, 400 - 450 parts of forsythia fruit, 400 - 450 parts of dandelion, 600 - 800 parts of gypsum, 320 - 380 parts of bitter apricot kernel, 180 - 240 parts of ephedra, 400 - 450 parts of bupleurum root, 320 - 380 parts of scutellaria baicalensis, 320 - 380 parts of anemarrhena rhizome, 400 - 450 parts of cicada slough, 320 - 380 parts of pogostemon cablin, 320 - 380 parts of dried tangerine peel, 600 - 800 parts of hawthorn fruit, 520 - 580 parts of coix seed, 400 - 450 parts of liquorice.

2. The traditional Chinese medicine preparation according to claim 1, characterized in that, the traditional Chinese medicine preparation is made from the following raw materials in parts by weight: 420 parts of honeysuckle flower, 420 parts of forsythia fruit, 420 parts of dandelion, 700 parts of gypsum, 350 parts of bitter apricot kernel, 210 parts of ephedra, 420 parts of bupleurum root, 350 parts of scutellaria baicalensis, 350 parts of anemarrhena rhizome, 420 parts of cicada slough, 350 parts of pogostemon cablin, 350 parts of dried tangerine peel, 700 parts of hawthorn fruit, 560 parts of coix seed, 420 parts of liquorice.

3. The traditional Chinese medicine preparation according to claim 1, characterized in that, the traditional Chinese medicine preparation is made from the following raw materials in parts by weight: 450 parts of honeysuckle flower, 400 parts of forsythia fruit, 450 parts of dandelion, 600 parts of gypsum, 380 parts of bitter apricot kernel, 240 parts of ephedra, 400 parts of bupleurum root, 320 parts of scutellaria baicalensis, 380 parts of anemarrhena rhizome, 450 parts of cicada slough, 380 parts of pogostemon cablin, 320 parts of dried tangerine peel, 800 parts of hawthorn fruit, 520 parts of coix seed, 400 parts of liquorice.

4. The traditional Chinese medicine preparation according to claim 1, characterized in that, the traditional Chinese medicine preparation is made from the following raw materials in parts by weight: 400 parts of honeysuckle flower, 450 parts of forsythia fruit, 400 parts of dandelion, 800 parts of gypsum, 320 parts of bitter apricot kernel, 180 parts of ephedra, 450 parts of bupleurum root, 380 parts of scutellaria baicalensis, 320 parts of anemarrhena rhizome, 400 parts of cicada slough, 320 parts of pogostemon cablin, 380 parts of dried tangerine peel, 600 parts of hawthorn fruit, 580 parts of coix seed, 450 parts of liquorice.

5. The preparation method of the traditional Chinese medicine preparation according to any one of claims 1 - 4, characterized in that, the preparation method comprises the following steps: Step (1): Take the above-mentioned honeysuckle flower, forsythia fruit, dandelion, gypsum, bitter apricot kernel, ephedra, bupleurum root, scutellaria baicalensis, anemarrhena rhizome, cicada slough, pogostemon cablin, dried tangerine peel, hawthorn fruit, coix seed, liquorice herbs, add 7 - 12 times the amount of water by weight of the herbs, decoct for 1 - 3 times, each decoction time is 0.5 - 2 hours, filter, and combine the above decoction filtrates; Step (2): Take the combined decoction filtrate of Step (1), concentrate and dry it into a clear paste, and then add pharmaceutically common excipients to make an oral preparation.

6. The preparation method of the traditional Chinese medicine preparation according to claim 5, characterized in that, in the said Step (1), add 10 times the amount of water by weight of the herbs, decoct for 2 times, and each decoction time is 1 hour.

7. The preparation method of the traditional Chinese medicine preparation according to claim 5, characterized in that, the oral preparation in the said Step (2) is: oral liquid, granule, pill, capsule, tablet.

8. Use of the traditional Chinese medicine preparation according to any one of claims 1 to 4 in the preparation of a medicament for treating upper respiratory tract infection, acute bronchitis, and mild pneumonia.

9. Use of the traditional Chinese medicine preparation according to any one of claims 1 to 4 in the preparation of a medicament for treating influenza.

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