Lung-clearing and detoxifying traditional Chinese medicine for shortening fever and cough time, dosage form and application

Abstract

The invention relates to the technical field of traditional Chinese medicines, in particular to a lung-clearing and detoxifying traditional Chinese medicine capable of shortening fever and cough time, a dosage form and application, and the lung-clearing and detoxifying traditional Chinese medicine is prepared from the following raw materials: 6 parts of honey-fried ephedra, 30 parts of gypsum, 15 parts of bupleurum chinense, 10 parts of scutellaria baicalensis, 15 parts of bran-fried rhizoma atractylodis, 30 parts of verbena, 10 parts of pogostemon cablin, 6 parts of raw liquorice, 10 parts of cynanchum glaucescens, 10 parts of radix stemonae and 10 parts of radix saposhnikoviae. Compared with the prior art, the traditional Chinese medicine formula for clearing lung, detoxifying and relieving cough has the following advantages: the traditional Chinese medicine formula for clearing lung, detoxifying and relieving cough has the same clinical curative effects in the aspects of relieving cough, relieving pharyngeal pain, relieving difficult expectoration and the like as traditional Chinese medicines and combined application of cold medicines; the traditional Chinese medicine formula for clearing away lung-heat, detoxifying and relieving cough is proved to have a good treatment effect on cough and related symptoms caused by influenza.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and in particular to a lung-clearing and detoxifying traditional Chinese medicine capable of shortening the time of fever and cough, a dosage form and an application thereof. Background Art

[0002] Influenza is a common disease. In 2019, the number of influenza cases in China was 3,538,213, 1,145,278 in 2020 and 668,246 in 2021. Influenza patients and latently infected people are the main sources of infection. They are contagious 1-7 days after onset and are most contagious 2-3 days after onset. The virus is transmitted through droplets in the air, contact between people, or contact with contaminated objects. The elderly, the young, and those who are bedridden are susceptible.

[0003] Clinical symptoms usually include fever, headache, cough, sore throat, muscle aches, and fatigue. In severe cases, serious symptoms such as pneumonia and respiratory failure may occur.

[0004] Influenza has an acute onset and severe symptoms, which seriously affects the daily life of patients and can even develop into a large-scale social flu. Therefore, it is particularly important to control the course of influenza in its early stages.

[0005] A Chinese patent (CN113499382A, October 15, 2021) discloses a traditional Chinese medicine composition and pharmaceutical preparation for clearing the lungs and detoxifying, as well as its preparation method and application, and specifically discloses the following content (paragraph 71): A traditional Chinese medicine composition, comprising 9g of raw ephedra, 30g of raw gypsum, 10g of bupleurum, 15g of scutellaria, 15g of artemisia annua, 10g of stir-fried atractylodes, 30g of verbena, 15g of patchouli and 10g of raw licorice.

[0006] A Chinese patent (CN 106421573A, February 22, 2017) discloses a medicine for treating cough and a preparation method thereof, and specifically discloses the following contents: 10 grams of Saposhnikovia divaricata, 10 grams of Perilla frutescens leaves, 10 grams of Schizonepeta tenuifolia, 10 grams of Platycodon grandiflorum, 15 grams of Aster tataricus, 15 grams of Stemona japonica, 10 grams of Bletilla striata, 10 grams of Citrus reticulata, and 5 grams of Licorice root.

[0007] However, the above patent documents do not provide a solution for reducing the duration of fever and coughing.

[0008] In addition, there is no Chinese medicine for clearing the lungs and detoxifying that can reduce the duration of fever and cough in other public information.

[0009] In view of this, the present invention is proposed. Summary of the invention

[0010] The purpose of the present invention is to provide a lung-clearing and detoxifying Chinese medicine, dosage form and application that can shorten the duration of fever and cough, and can reduce the duration of cough and fever caused by influenza.

[0011] In order to achieve the above-mentioned purpose of the present invention, the following technical solutions are particularly adopted:

[0012] A traditional Chinese medicine for clearing lungs and detoxifying for shortening the duration of fever and cough, prepared from the following raw materials:

[0013] 4-10 parts of roasted ephedra, 20-40 parts of gypsum, 10-20 parts of northern bupleurum, 5-15 parts of scutellaria, 10-20 parts of stir-fried atractylodes, 20-40 parts of verbena, 5-20 parts of patchouli, 4-10 parts of raw liquorice, 5-15 parts of white scutellaria, 5-15 parts of stemona, and 5-15 parts of siler.

[0014] A traditional Chinese medicine for clearing lungs and detoxifying for shortening the duration of fever and cough, prepared from the following raw materials:

[0015] 6 parts of roasted ephedra, 30 parts of gypsum, 15 parts of northern bupleurum, 10 parts of scutellaria, 15 parts of stir-fried atractylodes, 30 parts of verbena, 10 parts of patchouli, 6 parts of raw liquorice, 10 parts of white scutellaria, 10 parts of stemona, and 10 parts of siler.

[0016] The traditional Chinese medicine formula for clearing lungs, detoxifying and relieving cough is in the form of granules, decoctions, powders, pills, tablets, syrups, mixtures or oral liquids.

[0017] Application of a lung-clearing and detoxifying traditional Chinese medicine for shortening fever and coughing time in medicine for shortening fever time.

[0018] Application of a lung-clearing and detoxifying traditional Chinese medicine for shortening fever and coughing time in a medicine for reducing coughing time.

[0019] The lung-clearing and detoxifying traditional Chinese medicine, dosage form and application provided by the present invention for shortening the fever and coughing time have the following advantages compared with the prior art:

[0020] Firstly, the clinical efficacy of the lung-clearing and detoxifying Chinese medicine for shortening the fever and coughing time provided by the present invention in relieving cough, relieving throat pain, relieving difficulty in expectoration, etc. is the same as that of traditional Chinese medicine and combined cold medicine, and the incidence of adverse reactions is not significant, which proves that the Chinese medicine has a good therapeutic effect on cough and related symptoms caused by influenza.

[0021] Secondly, the lung-clearing and detoxifying Chinese medicine for shortening the fever and coughing time provided by the present invention is significantly superior to traditional Chinese medicine in terms of fever-reducing speed and time required for relieving cough. DETAILED DESCRIPTION

[0022] The following embodiments clearly and completely describe the technical solutions of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0023] The present invention provides a lung-clearing and detoxifying Chinese medicine formula for shortening the duration of fever and cough, and the compatibility idea is as follows:

[0024] A lung-clearing and detoxifying Chinese medicine that shortens the duration of fever and cough is derived from Ma Xing Gan Shi Tang, Zhisou San, and Xiao Chaihu Tang. Compared with traditional cough-relieving Chinese medicines, it emphasizes the effects of clearing lung heat and detoxifying on the basis of relieving cough and resolving phlegm. In clinical applications, it can not only relieve cough and resolve phlegm, and relieve symptoms such as cough and sore throat, but also quickly relieve fever and cough.

[0025] A traditional Chinese medicine formula for clearing the lungs and detoxifying that shortens the duration of fever and cough is prepared by modifying the classic Chinese medicine prescriptions of Ma Xing Gan Shi Tang, Zhi Sou San, and Xiao Chai Hu Tang.

[0026] Wind-heat attacks the surface, and the surface evil is not resolved and enters the interior, or the wind-cold evil is stagnant and turns into heat and enters the interior, and the evil heat fills the inside and outside, so the body heat is not resolved, the tongue coating is yellow, and the pulse is slippery and rapid. Heat is blocked in the lungs, and the lungs fail to descend, so cough, reverse breathing and shortness of breath. In the prescription: Ephedra is pungent and warm, it can open and promote lung qi to relieve asthma, open the pores, and relieve the surface to disperse the evil; Gypsum is pungent, sweet and very cold, it can clear the lung heat to produce body fluid, and it is pungent and dispersing to relieve muscles to expel the evil. The two medicines are one pungent and warm, and the other is pungent and cold; one is mainly used to promote lung qi, and the other is mainly used to clear lung qi, and both can expel the evil from the outside. When used together, they have the opposite meaning of complementing each other. They not only eliminate the cause of the disease, but also regulate the lung's function of spreading and dispersing, and they are used together as the main ingredient. Ephedra and Gypsum can promote lung qi and relieve asthma without adding heat; Gypsum and Ephedra can clear and relieve lung heat without suppressing coldness, and the two are used to control each other. Licorice can not only invigorate qi and harmonize the middle, but also produce body fluid and quench thirst when combined with gypsum, and can also mediate between cold and heat. The three herbs are used together, which is pungent and cool, dispels heat evils from the exterior and interior, relieves body heat and calms cough and asthma.

[0027] When wind evil invades the lungs, the lungs lose their ability to clear and purify, and the evil of the lung defense cannot be eliminated. The throat is the gateway to the lungs, so the throat itches and causes coughing. In the prescription:

[0028] The flavor of Fangdao is pungent and sweet, slightly warm in nature, and can dispel wind and relieve exterior pathogens, allowing the external evils to be eliminated through sweating.

[0029] Verbena is bitter and cold in nature, clearing away heat and detoxifying, and can be used to treat itchy and sore throat.

[0030] Stemona tuber is bitter in taste and enters the lung meridian. It is warm but not hot, moist but not greasy, and can moisten the lungs, astringe and relieve cough. Baiqian is pungent, sweet and neutral in nature. It enters the lung meridian and is good at descending qi, resolving phlegm and relieving cough. It can be used for both cold and heat syndromes.

[0031] Bupleurum is pungent and cold in nature, and has the effect of soothing the qi in the chest; Scutellaria helps Bupleurum to dispel the pathogenic heat in the Shaoyang meridian;

[0032] Patchouli, dispels dampness from the exterior, uses its aromatic aroma to dissolve dampness and turbidity inside the body;

[0033] Stir-fried Atractylodes lancea with bran can dry out dampness and strengthen the spleen, dispel wind and cold, prevent bitter and cold medicines from damaging the spleen and stomach, and help Patchouli to eliminate dampness.

[0034] Ma Xing Gan Shi Tang is mainly used to treat the syndrome of pathogenic heat blocking the lungs caused by exogenous wind evil. Symptoms include persistent fever, cough, shortness of breath. Ma Xing Gan Shi Tang dissipates qi to relieve asthma and opens the pores to disperse evil. Dissipating the lungs is combined with descending qi, with dissipation as the main method. Dissipating the exterior and clearing the lungs are used together, with clearing as the main method. The Chinese medicine formula for clearing the lungs, detoxifying and relieving cough is guided by the lung qi harmonization method of Professor Fang Heqian, a master of traditional Chinese medicine, emphasizing that it is appropriate to dissipate and descend in the treatment of cough, and that dissipating and purging the lungs complement each other. Dissipation can promote descent, and descent can help dissipation, so that the upper part is connected to the lower part, and the lung qi is unobstructed. Therefore, the Chinese medicine formula for clearing the lungs, detoxifying and relieving cough is based on Ma Xing Gan Shi Tang, and two flavors of Baiqian and Baibu in Zhisou San are added, which have astringent properties. Dissipation has astringency, dissipation and purging are coordinated, and dissipation and astringency are combined. In view of the characteristics of Ma Xing Gan Shi Tang that it is mainly dissipation, astringent products are added, and addition and subtraction are flexibly added to achieve the purpose of regulating lung qi and stopping cough. Because lung qi is blocked, it is not suitable to simply promote lung function, which will result in lung qi and phlegm turbidity not descending, but will damage lung qi, so Baiqian and Stemona are added to harmonize and promote. At the beginning of the disease, wind is restrained in the lung, Wei qi is blocked, and lung qi cannot be promoted. At this time, if Baiqian and Stemona are simply used to astringe and relieve cough, it will close the door to keep the enemy, lead the evil into the interior or the evil will linger, so Ephedra and Apricot kernel are added to promote lung qi and regulate the qi.

[0035] Professor Fang Heqian has four methods of clinical treatment of cough and asthma: "promoting, drying, dispersing, and supplementing", namely, promoting lung function, drying dampness, dispersing liver function, and supplementing kidney function. Liver depression turns into fire, which is easy to burn the lung metal, causing the lung to lose its ability to promote and descend, resulting in persistent cough. The Chinese medicine formula for clearing lungs, detoxifying, and relieving cough is aimed at the symptoms of patients with stagnant heat and fullness in the chest and ribs. It uses two ingredients, bupleurum and scutellaria, from the classic formula Xiao Chaihu Decoction. Bupleurum is used to dissipate the evil of Shaoyang and relieve stagnation, while scutellaria is used to clear and discharge the heat of Shaoyang half-exterior and half-interior. The ascending and dispersing effect of bupleurum is combined with the descending and dispersing effect of scutellaria. The combination of ascending and descending can penetrate heat and relieve depression, restore liver function, and regulate qi, thus enhancing the antipyretic effect of the Chinese medicine formula for clearing lungs, detoxifying, and relieving cough. Xiao Chaihu Decoction has the function of reconciling Shaoyang, but does not have the function of promoting lung function and relieving cough. The Chinese medicine formula for clearing the lungs, detoxifying and relieving cough includes bupleurum, scutellaria, ephedra, apricot kernel, scutellaria baicalensis and radix stemonae, which can harmonize yang, soothe the liver, and regulate qi to help relieve cough and reduce fever.

[0036] A lung-clearing and detoxifying traditional Chinese medicine for shortening the duration of fever and cough is prepared from the following ingredients: 4-10 parts of roasted ephedra, 20-40 parts of raw gypsum, 10-20 parts of northern bupleurum, 5-15 parts of scutellaria, 10-20 parts of bran-fried atractylodes, 20-40 parts of verbena, 5-20 parts of patchouli, 4-10 parts of raw liquorice, 5-15 parts of radix scutellariae, 5-15 parts of stemonae and 5-15 parts of siler.

[0037] The best embodiment is:

[0038] 6 parts of roasted ephedra, 30 parts of gypsum, 15 parts of northern bupleurum, 10 parts of scutellaria, 15 parts of stir-fried atractylodes, 30 parts of verbena, 10 parts of patchouli, 6 parts of raw liquorice, 10 parts of white scutellaria, 10 parts of stemona, and 10 parts of siler.

[0039] The traditional Chinese medicine formula for clearing lungs and detoxifying for shortening the time of fever and cough can be in the form of granules, decoctions, powders, pills or tablets.

[0040] The preparation method is specifically described below using granules as an example:

[0041] Roasted Ephedra: Take honey ephedra slices, add 8-10 times the amount of water, decoct for 1-2 hours, and filter through 300 mesh. Add 6-8 times the water again, decoct for 1-2 hours, filter through 300 mesh, and combine the two filtrates. Vacuum dry and concentrate at 60-80℃ to obtain an ointment, and the ointment density is 1.00-1.10 at 70±5℃. After spray drying, sieve through 80-150 mesh to obtain the extract powder. Weigh the honey ephedra formula granules (extract powder), and evenly add 0.3% silicon dioxide, 0.1% magnesium stearate, and maltodextrin to make up the granules, and pass through 30 mesh sieves respectively. Mix the raw and auxiliary materials evenly and granulate them to make 1000g of 2800g slices.

[0042] Gypsum: This product is a sulfate mineral anhydrite family gypsum, mainly containing hydrated calcium sulfate (CaSO4·2H2O). After excavation, remove the miscellaneous stones and sand. Weigh the gypsum formula particles (extract powder), pass through an 80-mesh sieve, and evenly add maltodextrin that has passed an 80-mesh sieve, so that 20,000g of the decoction piece can be made into 1,000g of extract.

[0043] Northern Bupleurum: Take the Northern Bupleurum slices, add 8-10 times the amount of water, decoct for 1-2 hours, and filter through 300 mesh. Add 6-8 times the water again, decoct for 1-2 hours, filter through 300 mesh, and combine the two filtrates. Vacuum dry and concentrate at 60-80℃ to obtain an ointment, and the ointment density is 1.18-1.23 at 70±5℃. After spray drying, sieve through 80 mesh to obtain the extract powder. Weigh the Northern Bupleurum formula granules (extract powder), and evenly add 0.3% silicon dioxide, 0.1% magnesium stearate, and maltodextrin to make up the granules, and pass through 30 mesh sieves respectively. Mix the raw and auxiliary materials evenly and granulate them to make 1000g of 4000g slices.

[0044] Scutellaria: Take the slices of Scutellaria, add 8-10 times the amount of water, decoct for 1-2 hours, and filter through 300 mesh. Add 6-8 times the water again, decoct for 1-2 hours, filter through 300 mesh, and combine the two filtrates. Vacuum dry and concentrate at 60-80℃ to obtain an ointment, and the ointment density is 1.00-1.10 at 70±5℃. After spray drying, sieve through 80-150 mesh to obtain the extract powder. Weigh the formula granules of Scutellaria (extract powder), and evenly add 0.3% silicon dioxide, 0.1% magnesium stearate, and maltodextrin to make up the granules, and pass through 30 mesh sieves respectively. Mix the raw materials and excipients evenly and granulate them to make 1000g of 2200g slices.

[0045] Fried Atractylodes with bran: Take Atractylodes slices, add 8-10 times the amount of water, decoct for 1-2 hours, and filter through 300 mesh. Add 6-8 times the water again, decoct for 1-2 hours, filter through 300 mesh, and combine the two filtrates. Vacuum dry and concentrate at 60-80℃ to obtain an ointment, and the ointment density is 1.03-1.10 at 70±5℃. After spray drying, sieve through 80-150 mesh to obtain the extract powder. Weigh the Atractylodes (Northern Atractylodes) formula granules (extract powder), and evenly add 0.3% silicon dioxide, 0.1% magnesium stearate, and maltodextrin to make up the granules, and pass through 30 mesh sieves respectively. Mix the raw and auxiliary materials evenly and granulate them to make 1000g of 2700g slices.

[0046] Verbena: Take verbena slices, add 8-10 times the amount of water, decoct for 1-2 hours, and filter through 300 mesh. Add 6-8 times the water again, decoct for 1-2 hours, filter through 300 mesh, and combine the two filtrates. Vacuum dry and concentrate at 60-80℃ to obtain an ointment, and the ointment density is 1.00-1.10 at 70±5℃. After spray drying, sieve through 80-150 mesh to obtain the extract powder. Weigh the verbena formula granules (extract powder), and evenly add 0.3% silicon dioxide, 0.1% magnesium stearate, and maltodextrin to make up the granules, and pass through 30 mesh sieves respectively. Mix the raw and auxiliary materials evenly and granulate them to make 1000g of 6700g slices.

[0047] Patchouli: Take patchouli slices, add 8-10 times the amount of water, decoct for 1-2 hours, and filter through 300 mesh. Add 6-8 times the amount of water again, decoct for 1-2 hours, filter through 300 mesh, and combine the two filtrates. Vacuum dry and concentrate at 60-80℃ to obtain an ointment, and the ointment density is 1.00-1.10 at 70±5℃. After spray drying, sieve through 80-150 mesh to obtain an extract powder. Weigh the patchouli formula granules (extract powder), and evenly add 0.3% silicon dioxide, 0.1% magnesium stearate, and maltodextrin to make up the granules, and pass through a 30-mesh sieve respectively. Mix the raw and auxiliary materials evenly and granulate them to make 1000g of 2200g slices.

[0048] Raw licorice: Take raw licorice slices, add 8-10 times the amount of water, decoct for 1-2 hours, and filter through 300 mesh. Add 6-8 times the water again, decoct for 1-2 hours, filter through 300 mesh, and combine the two filtrates. Vacuum dry and concentrate at 60-80℃ to obtain an ointment, and the ointment density is 1.04-1.08 at 70±5℃. After spray drying, sieve through 80-150 mesh to obtain an extract powder. Weigh the licorice formula granules (extract powder), and evenly add 0.3% silicon dioxide, 0.1% magnesium stearate, and maltodextrin to make up the granules, and pass through a 30-mesh sieve respectively. Mix the raw and auxiliary materials evenly and granulate them to make 1000g of 3000g slices.

[0049] Baiqian: Take Baiqian slices, add 8-10 times the amount of water, decoct for 1-2 hours, and filter through 300 mesh. Add 6-8 times the water again, decoct for 1-2 hours, filter through 300 mesh, and combine the two filtrates. Vacuum dry and concentrate at 60-80℃ to obtain an ointment, and the ointment density is 1.00-1.10 at 70±5℃. After spray drying, sieve through 80-150 mesh to obtain the extract powder. Weigh the Baiqian (Liuye Baiqian) formula granules (extract powder), and evenly add 0.3% silicon dioxide, 0.1% magnesium stearate, and maltodextrin to make up the granules, and pass through 30 mesh sieves respectively. Mix the raw and auxiliary materials evenly and granulate them to make 1000g of 4000g slices.

[0050] Stemona: Take the slices of Stemona, add 8-10 times the amount of water, decoct for 1-2 hours, and filter through 300 mesh. Add 6-8 times the water again, decoct for 1-2 hours, filter through 300 mesh, and combine the two filtrates. Vacuum dry and concentrate at 60-80℃ to obtain an ointment, and the ointment density is 1.10-1.30 at 70±5℃. After spray drying, sieve through 80-150 mesh to obtain the extract powder. Weigh the formula granules (extract powder) of Stemona (opposite-leaved Stemona), and evenly add 0.3% silicon dioxide, 0.1% magnesium stearate, and maltodextrin to make up the granules, and pass through 30 mesh sieves respectively. Mix the raw materials and excipients evenly and granulate them to make 1000g of 1400g slices.

[0051] Fangfeng: Take Fangfeng slices, add 8-10 times the amount of water, decoct for 1-2 hours, and filter through 300 mesh. Add 6-8 times the water again, decoct for 1-2 hours, filter through 300 mesh, and combine the two filtrates. Vacuum dry and concentrate at 60-80℃ to obtain an ointment, and the ointment density is 1.20-1.25 at 70±5℃. After spray drying, sieve through 80-150 mesh to obtain the extract powder. Weigh the Fangfeng formula granules (extract powder), and evenly add 0.3% silicon dioxide, 0.1% magnesium stearate, and maltodextrin to make up the granules, and pass through 30 mesh sieves respectively. Mix the raw and auxiliary materials evenly and granulate them to make 1000g of 2000g slices.

[0052] The Chinese medicine formula for clearing lungs, detoxifying and relieving cough of the present invention can be obtained by combining the above-mentioned roasted ephedra, raw gypsum, northern bupleurum, baicalin, bran-fried atractylodes, verbena, patchouli, raw licorice, radix scutellariae, stemonae and saposhnikoviae according to the scores.

[0053] In addition, the quality control method for the Chinese medicine formula granules for clearing lungs, detoxifying and relieving cough is as follows:

[0054] Roasted Ephedra:

[0055]

Identification

[0056] Take 1 g of this product, grind it into powder, add a few drops of concentrated ammonia test solution and 10 ml of chloroform, heat and reflux for 1 hour, filter, evaporate the filtrate to dryness, add 2 mL of methanol to the residue, shake it thoroughly, filter, and take the filtrate as the test solution.

[0057] Take another 1g of Ephedra sinica reference medicinal material, add 50ml of water, boil for 30 minutes, filter, evaporate the filtrate to dryness, and prepare the reference medicinal material solution in the same way as the residue starting from "add 2ml of methanol".

[0058] Take the ephedrine hydrochloride reference substance and add methanol to make a solution containing 1 mg per 1 ml as the reference substance solution.

[0059] According to the thin layer chromatography method (Chinese Pharmacopoeia 2020 General Rules 0502), 5 μl of the control medicinal material and reference substance solution and 10 μl of the test solution were taken and spotted on the same silica gel G thin layer plate, respectively, with chloroform-methanol-concentrated ammonia test solution (20:5:0.5) as the developing agent, developed, taken out, dried, sprayed with ninhydrin test solution, and heated at 105°C until the spots were clearly colored. In the chromatogram of the test sample, spots of the same color (ephedrine hydrochloride) appeared at the corresponding positions of the chromatogram of the control medicinal material and the chromatogram of the reference substance.

[0060]

Content determination

[0061] Polar ether-connected phenyl bonded silica gel is used as filler; methanol is used as mobile phase A, 0.092% phosphoric acid solution (containing 0.04% triethylamine and 0.02% di-n-butylamine, 1.5:98.5) is used as mobile phase B, and gradient elution is performed according to the provisions in the following table; the column temperature is not higher than 25°C; the flow rate is 0.7ml per minute, and the detection wavelength is 210nm. The theoretical plate number calculated based on the ephedrine hydrochloride peak should be no less than 3000.

[0062]

[0063] Preparation of reference solution: Take appropriate amounts of ephedrine hydrochloride reference substance and pseudoephedrine hydrochloride reference substance, weigh them accurately, and add methanol to make a mixed solution containing 40 μg in 1 mL.

[0064] Preparation of test solution: Take an appropriate amount of the product, grind it into powder, take about 0.5 g, put it in a stoppered conical flask, accurately add 25 mL of 70% methanol, weigh the weight, ultrasonically treat (power 500 W, frequency 40 kHz) for 30 minutes, cool, weigh the weight, make up the weight with 70% methanol, shake well, filter, and take the filtrate.

[0065] Determination method: Accurately pipette 10μl of reference solution and test solution respectively, inject into liquid chromatograph, and determine. 10 H 15 NO·HCl) and pseudoephedrine hydrochloride (C 10 H 15 The total amount of NO·HCl) is 12.0 mg to 30.0 mg.

[0066] Gypsum

[0067] The sum of the amount that cannot pass through the No. 1 sieve and the amount that can pass through the No. 5 sieve shall not exceed 12%. The water content shall not exceed 7.0%. It should be completely dissolved in water or slightly turbid. There shall be no foreign matter or burnt debris.

[0068] Bupleurum chinense

[0069]

Identification

[0070] Take 0.5g of this product, grind it into powder, add 20ml of methanol, ultrasonically treat it for 10 minutes, filter it, and concentrate the filtrate to 2ml as the test solution. Take another 1g of Bupleurum (Northern Bupleurum) reference medicinal material, add 50ml of water, decoct it for 30 minutes, filter it, evaporate the filtrate to dryness, add 20ml of methanol to the residue, and prepare the reference medicinal material solution in the same way. Take the reference substance of Bupleurum saponin a, add methanol to make a solution containing 0.5mg per 1ml, as the reference substance solution. According to the thin layer chromatography method (General Rules 0502 of the 2020 edition of the Chinese Pharmacopoeia), 3 μl of the above-mentioned test solution and reference solution and 6 μl of the reference medicinal material solution were taken and spotted on the same silica gel G thin layer plate, ethyl acetate-ethanol-water (8:2:1) was used as the developing solvent, pre-saturated for 30 minutes, developed, taken out, dried, sprayed with 2% p-dimethylaminobenzaldehyde in 40% sulfuric acid solution, heated at 60°C until the spots were clearly colored, and examined under sunlight and ultraviolet light (365nm). In the chromatogram of the test sample, spots of the same color or fluorescent spots appeared at the corresponding positions of the chromatograms of the reference medicinal material and the reference substance, respectively.

[0071]

Content determination

[0072] Octadecylsilane bonded silica gel is used as filler (column length is 100 mm, inner diameter is 2.1 mm, particle size is 1.7 μm); acetonitrile is used as mobile phase A, water is used as mobile phase B, and gradient elution is performed according to the provisions in the following table; detection wavelength is 211 nm, 250 nm; column temperature is 35°C; flow rate is 0.4 ml per minute. The theoretical plate number calculated based on the saikosaponin a peak should not be less than 10,000.

[0073]

[0074] Preparation of reference solution: Take an appropriate amount of saikosaponin a reference substance, weigh it accurately, and add methanol to make a solution containing 75 μg per 1 ml.

[0075] Preparation of test solution: Take an appropriate amount of the product, grind it into powder, take about 1.0 g, weigh it accurately, put it in a stoppered conical flask, accurately add 25 ml of 5% ethanol solution containing 5% concentrated ammonia test solution, stopper it tightly, weigh it, treat it with ultrasound (power 250 W, frequency 40 kHz) for 30 minutes, let it cool, weigh it again, make up the lost weight with 5% ethanol solution containing 5% concentrated ammonia test solution, shake it well, filter it, and take the filtrate to obtain it.

[0076] Determination method: Accurately pipette 3 μl of reference solution and test solution respectively, inject into liquid chromatograph, and determine. 42 H 68 O 13 ) should be 1.60mg~5.00mg.

[0077] Scutellaria baicalensis

[0078]

Identification

[0079] Take 0.5g of this product, grind it, add 20ml of methanol, ultrasonically treat it for 30 minutes, filter it, evaporate the filtrate, and add 2ml of methanol to dissolve the residue as the test solution. Take another 1g of Scutellaria baicalensis reference medicinal material and prepare the reference medicinal material solution in the same way. Then take baicalin reference substance, baicalein reference substance, and wogonin reference substance, add methanol to prepare solutions containing 1mg, 0.5mg, and 0.5mg per 1ml respectively as the reference solution. According to the thin layer chromatography method (General Rules 0502 of the 2020 Edition of the Chinese Pharmacopoeia), 2μl of the test solution, the reference medicinal material solution, and 1μl of the above three reference solution were taken and spotted on the same polyamide film, and toluene-ethyl acetate-methanol-formic acid (10:3:1:2) was used as the developing agent. Pre-saturation for 30 minutes, development, removal, drying, and inspection under ultraviolet light (365nm). In the chromatogram of the test sample, a main spot of the same color appears at the corresponding position in the chromatogram of the reference medicinal material; and three identical dark spots appear at the corresponding position in the chromatogram of the reference sample.

[0080]

Content determination

[0081] Octadecylsilane bonded silica gel was used as the filler (column length: 100 mm, inner diameter: 2.1 mm, particle size: 1.8 μm); methanol-water-phosphoric acid (47:53:0.05) was used as the mobile phase; the flow rate was 0.35 ml per minute; the column temperature was 30°C; the detection wavelength was 280 nm. The theoretical plate number calculated based on the baicalin peak should be no less than 2500.

[0082]

[0083] Preparation of reference solution: Take an appropriate amount of baicalin reference substance, weigh it accurately, and add methanol to make a solution containing 25 μg per 1 ml.

[0084] Preparation of test solution Take an appropriate amount of the product, grind it into powder, take about 0.1g, weigh it accurately, put it in a 100ml volumetric flask, add an appropriate amount of water to dissolve it, add water to the scale, shake it well. Accurately measure 1ml, put it in a 10ml volumetric flask, add methanol to the scale, shake it well, and you have it.

[0085] Determination method: Accurately pipette 1 μl of reference solution and test solution respectively, inject into liquid chromatograph, and determine. 21 H 18 O 11 ) should be 148.0mg~274.0mg.

[0086] Fried Atractylodes macrocephala with bran

[0087]

Identification

[0088] Take 1g of this product, grind it, add 30ml of water to dissolve it, shake and extract it with ethyl acetate three times, 20ml each time, combine the ethyl acetate solution, evaporate to dryness, add 1.5ml of ethyl acetate to dissolve the residue, and use it as the test solution. Take 0.5g of the reference medicinal material of Atractylodes lancea (Northern Atractylodes), add 50ml of water, boil for 30 minutes, filter, take the filtrate, shake and extract it with ethyl acetate three times, and prepare the reference medicinal material solution in the same way. According to the thin layer chromatography method (General Rules 0502 of the 2020 Edition of the Chinese Pharmacopoeia), take 10μl of the above test solution and reference medicinal material solution, respectively, and spot them on the same silica gel G thin layer plate, use n-hexane-ethyl acetate-glacial acetic acid (4:3:0.1) as the developing agent, pre-saturate for 30 minutes, develop, take out, dry, and examine under ultraviolet light (365nm). In the chromatogram of the test product, fluorescent spots of the same color appear at the corresponding position of the chromatogram of the reference medicinal material.

[0089]

Content determination

[0090] A chromatographic column with octadecylsilane bonded silica as filler (column length: 100 mm, inner diameter: 2.1 mm, particle size: 1.8 μm); acetonitrile as mobile phase A, 0.1% formic acid as mobile phase B, gradient elution as specified in the following table; detection wavelength: 284 nm for 0-8.5 minutes, 336 nm for 8.5-45 minutes, flow rate: 0.4 ml per minute; column temperature: 30°C; theoretical plate number calculated based on chlorogenic acid peak should be not less than 5000.

[0091]

[0092] Preparation of reference solution Take an appropriate amount of chlorogenic acid reference substance, weigh accurately, add 10% methanol to make a solution containing 20 μg of chlorogenic acid per 1 ml, filter and use it as the reference solution.

[0093] Preparation of test solution: Take an appropriate amount of the product, grind it into powder, take about 0.5 g, weigh it accurately, put it in a stoppered conical flask, accurately add 20 ml of 10% methanol, stopper it tightly, weigh it, and treat it with ultrasound (power 250 W, frequency 40 kHz) for 40 minutes. Take it out, cool it, weigh it again, make up the lost weight with 10% methanol, shake it well, filter it, and take the filtrate to obtain it.

[0094] Determination method: Accurately pipette 5μl of reference solution and test solution respectively, inject into liquid chromatograph, and determine. 16 H 18 O9) should be 0.086mg~0.650mg.

[0095] Verbena

[0096]

Identification

[0097] Take 1g of this product, grind it, add 20ml of dichloromethane, and ultrasonically treat it for 30 minutes. Discard the dichloromethane solution, add 10ml of methanol to the residue, and ultrasonically treat it for 30 minutes. Filter it, and use the filtrate as the test solution. Take another 1g of verbena reference medicinal material and make a reference medicinal material solution in the same way. Take the verbena glycoside reference substance and the verbena glycoside reference substance, respectively, and add methanol to make a solution containing 0.1mg per 1ml as the reference solution. According to the thin layer chromatography method (General Rules 0502 of the 2020 Edition of the Chinese Pharmacopoeia), take 8μl of the test solution and the reference medicinal material solution, and 5μl of the reference solution, and spot them on the same silica gel GF254 thin layer plate, use ethyl acetate-methanol-water (9:2:1) as the developing agent, develop, take out, dry, and inspect under ultraviolet light (254nm). In the chromatogram of the test sample, spots of the same color appear at the corresponding positions of the chromatogram of the reference medicinal material and the chromatogram of the reference substance; spray with 10% sulfuric acid ethanol 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 positions of the chromatogram of the reference medicinal material and the chromatogram of the reference substance.

[0098]

Content determination

[0099] Octadecylsilane bonded silica gel was used as the filler (column length: 100 mm, inner diameter: 2.1 mm, particle size: 1.7 μm); acetonitrile was used as mobile phase A, 0.1% formic acid solution was used as mobile phase B, and gradient elution was performed according to the provisions in the following table; the flow rate was 0.4 ml per minute; the column temperature was 30°C; the detection wavelength was 239 nm. The theoretical plate number calculated based on the verbena glycoside peak should be no less than 3000.

[0100]

[0101] Preparation of reference solution: Take appropriate amounts of verbena glycoside reference substance and verbena glycoside reference substance, weigh them accurately, and add methanol to each of them to make solutions containing 0.2 mg of each per 1 ml.

[0102] Preparation of test solution: Take an appropriate amount of the product, grind it into powder, take about 0.1 g, weigh it accurately, put it in a stoppered conical flask, accurately add 25 ml of 70% methanol, stopper it tightly, weigh it, treat it with ultrasound (power 300 W, frequency 40 kHz) for 20 minutes, let it cool, weigh it again, make up the lost weight with 70% methanol, shake it well, filter it, and take the filtrate to obtain the solution.

[0103] Determination method: Accurately pipette 2μl of reference solution and test solution respectively, inject into ultra-high performance liquid chromatography, and determine. 17 H 24 O 10 ) should be 8.0mg~60.0mg, containing verbena glycoside (C 17 H 24 O 11 ) should be 10.0mg~50.0mg.

[0104] Patchouli

[0105]

Identification

[0106] Take 2g of this product, grind it, add 20ml of hot water and shake for 10 minutes, and let it cool. Add petroleum ether (30-60℃) and shake to extract 3 times, 25ml each time, combine the petroleum ether solution, evaporate, and add 1ml of ethyl acetate to the residue to dissolve it as the test solution. Take another reference substance of Patchouli alcohol, add ethyl acetate to make a solution containing 2mg per 1ml as the reference solution. According to the thin layer chromatography method (General Rules 0502 of the 2020 Edition of the Chinese Pharmacopoeia), take 10μl of the above test solution and 1μl of the reference solution, and spot them on the same silica gel G thin layer plate, with petroleum ether (30-60℃)-ethyl acetate-formic acid (10:1:0.05) as the developing agent, pre-saturate for 30 minutes, develop, take out, dry, spray with 5% vanillin sulfuric acid ethanol solution, heat at 105℃ until the spots are clear, and inspect under sunlight. In the chromatogram of the test sample, the same purple-red spots appear at the corresponding position of the chromatogram of the reference medicinal material.

[0107]

Content determination

[0108] The chromatographic column is filled with octadecylsilane bonded silica gel (column length is 100 mm, inner diameter is 2.1 mm, particle size is 1.7 μm); methanol is used as mobile phase A, 0.1% formic acid solution is used as mobile phase B, and gradient elution is performed as specified in the following table; the flow rate is 0.3 ml per minute; the column temperature is 40°C; the detection wavelength is 310 nm, and the theoretical plate number calculated based on the patchouli ketone peak should not be less than 3000.

[0109]

[0110]

[0111] Preparation of reference solution: Take an appropriate amount of patchouli ketone reference substance, weigh it accurately, and add methanol to make a solution containing 40 μg per 1 ml as the reference solution.

[0112] Preparation of test solution: Take an appropriate amount of the product, grind it into powder, take about 0.2 g, weigh it accurately, put it in a stoppered conical flask, add 20 ml of methanol and weigh it accurately, treat it with ultrasound (power 250 W, frequency 40 kHz) for 30 minutes, take it out, cool it, weigh it again, make up the lost weight with methanol, shake it well, filter it, and take the filtrate to obtain it.

[0113] Determination method: Accurately pipette 2μl of reference solution and test solution respectively, inject into liquid chromatograph, and determine. 12 H 16 O4) should be 0.7mg~3.0mg.

[0114] Raw licorice

[0115]

Identification

[0116] Take 0.2g of this product, grind it into powder, add 20ml of water to dissolve it, shake and extract it twice with n-butanol saturated with water, 20ml each time, combine the n-butanol solution, evaporate to dryness, add 5ml of methanol to dissolve the residue, and use it as the test solution. Take another 0.5g of licorice (licorice) reference medicinal material, add 50ml of water, boil for 30 minutes, filter, concentrate the filtrate to 20ml, and prepare the reference medicinal material solution in the same way. Take the ammonium glycyrrhizinate reference substance, add methanol to make a solution containing 2mg per 1ml, and use it as the reference substance solution. According to the thin layer chromatography method (Chinese Pharmacopoeia 2020 Edition General Rules 0502), 2 μl of each of the above three solutions were taken and spotted on the same silica gel G thin layer plate prepared with 1% sodium hydroxide solution, and ethyl acetate-formic acid-glacial acetic acid-water (15:1:1:2) was used as the developing agent. After development, the plate was taken out, dried, sprayed with 10% sulfuric acid ethanol solution, heated at 105°C until the spots were clearly colored, and examined under ultraviolet light (365nm). In the chromatogram of the test sample, fluorescent spots of the same color appeared at the corresponding positions of the chromatogram of the reference medicinal material and the chromatogram of the reference sample.

[0117]

Content determination

[0118] Octadecylsilane bonded silica gel is used as filler (column length is 100 mm, inner diameter is 2.1 mm, particle size is 2.2 μm); acetonitrile is used as mobile phase A, 0.05% phosphoric acid solution is used as mobile phase B, and gradient elution is performed as specified in the following table; the flow rate is 0.4 ml per minute; the detection wavelength is 237 nm. The theoretical plate number calculated based on the glycyrrhizin peak should not be less than 5000.

[0119]

[0120]

[0121] Preparation of reference solution: Take appropriate amounts of liquiritin reference substance and ammonium glycyrrhizinate reference substance, weigh accurately, add 70% ethanol to prepare a solution containing 60 μg liquiritin and 0.1 mg ammonium glycyrrhizinate per 1 ml, namely (weight of glycyrrhizic acid = weight of ammonium glycyrrhizinate / 1.0207).

[0122] Preparation of test solution: Take an appropriate amount of the product, grind it into powder, take about 0.1 g, weigh it accurately, put it in a stoppered conical flask, accurately add 50 ml of 70% ethanol, stopper it tightly, weigh it, and treat it with ultrasound (power 250 W, frequency 40 kHz) for 30 minutes. Let it cool, weigh it again, make up the lost weight with 70% ethanol, shake it well, filter it, and take the filtrate to obtain the solution.

[0123] Determination method: Accurately pipette 1 μl of reference solution and test solution respectively, inject into liquid chromatograph, and determine. 21 H 22 O9) should be 15.0mg~35.0mg, containing glycyrrhizic acid (C42 H 62 O 16 ) should be 29.0mg~80.0mg.

[0124] Bai Qian

[0125]

Identification

[0126] Take 0.4g of this product, grind it, add 0.5ml of water to moisten it, then add 10ml of water-saturated n-butanol, ultrasonically treat it for 30 minutes, let it stand, take the supernatant and add 3 times the amount of ammonia test solution, shake it well, let it stand to separate, take the upper layer and evaporate it to dryness, add 1ml of methanol to the residue to dissolve it, and use it as the test solution. Take another 2g of the control medicinal material of Baiqian (Liuye Baiqian), add 100ml of water, decoct it for 30 minutes, filter it, concentrate the filtrate to nearly dryness, add 10ml of water-saturated n-butanol to the residue, and prepare the control medicinal material solution in the same way. According to the thin layer chromatography method (Chinese Pharmacopoeia 2020 General Rules 0502), 10 μl of each of the above two solutions were taken and spotted on the same silica gel G thin layer plate, and toluene-acetone (4:1) was used as the developing agent. After development, the plate was taken out, dried, sprayed with 10% sulfuric acid ethanol solution, heated at 105°C until the spots were clearly colored, and examined under ultraviolet light (365nm). In the chromatogram of the test sample, fluorescent spots of the same color appeared at the corresponding position of the chromatogram of the control medicinal material.

[0127]

Content determination

[0128] Octadecylsilane bonded silica gel was used as the filler (column length: 100 mm, inner diameter: 2.1 nm, particle size: 1.8 μm); acetonitrile was used as mobile phase A, 0.1% formic acid solution was used as mobile phase B, and gradient elution was performed according to the provisions in the following table; the flow rate was 0.3 ml per minute; the column temperature was 30°C; the detection wavelength was 260 nm. The theoretical plate number calculated based on the vanillic acid peak should not be less than 5000.

[0129]

[0130] Preparation of reference solution: Take an appropriate amount of vanillic acid reference substance, weigh accurately, and add methanol to make a solution containing 16 μg per 1 ml.

[0131] Preparation of test solution: Take an appropriate amount of the product, grind it into powder, take about 1.5 g, weigh it accurately, put it in a stoppered conical flask, accurately add 10 ml of 70% methanol, stopper it tightly, weigh it, treat it with ultrasound (power 250 W, frequency 40 kHz) for 15 minutes, let it cool, weigh it again, make up the lost weight with 70% methanol, shake it well, filter it, and take the filtrate to obtain the solution.

[0132] Determination method: Accurately pipette 1 μl of reference solution and test solution respectively, inject into ultra-high performance liquid chromatography, and determine. Each 1g of this product should contain 0.03mg to 0.25mg of vanillic acid (C8H8O4).

[0133] Baibu

[0134]

Identification

[0135] Take 1g of this product, grind it, add 20ml of ethanol and 1ml of hydrochloric acid, heat and reflux for 30 minutes, cool, filter, evaporate the filtrate, add 1ml of methanol to the residue to dissolve it as the test solution. Take another 0.5g of the control medicinal material of Stemona (Right Leaf Stemona), add 50ml of water, boil for 30 minutes, filter, evaporate the filtrate, add 20ml of ethanol and 1ml of hydrochloric acid to the residue, and prepare the control medicinal material solution in the same way. According to the thin layer chromatography method (General Rules 0502 of the 2020 Edition of the Chinese Pharmacopoeia), take 4μl of each of the above two solutions, spot them on the same silica gel G thin layer plate, use toluene-ethyl acetate-formic acid (4:2:0.5) as the developing agent, develop, take out, dry, and examine under ultraviolet light (365nm). In the chromatogram of the test product, fluorescent spots of the same color appear at the corresponding position of the chromatogram of the control medicinal material.

[0136]

Content determination

[0137] Octadecylsilane bonded silica gel is used as filler (column length is 100 mm, inner diameter is 2.1 mm, particle size is 1.7 μm); acetonitrile is used as mobile phase A, 0.1% phosphoric acid solution is used as mobile phase B; gradient elution is performed according to the provisions in the following table; flow rate is 0.25 ml per minute; column temperature is 25°C; detection wavelength is 325 nm. The theoretical plate number calculated based on the chlorogenic acid peak should be no less than 35,000.

[0138]

[0139] Preparation of reference solution: Take an appropriate amount of chlorogenic acid reference substance, weigh it accurately, and add methanol to make a solution containing 5 μg per 1 ml.

[0140] Preparation of test solution: Take an appropriate amount of the product, grind it into powder, take about 0.1g, weigh it accurately, put it in a 25ml volumetric flask, add about 15ml of 70% ethanol, ultrasonically treat (power 500W, frequency 40kHz) for 10 minutes, cool it, add 70% ethanol to the scale, shake it well, filter it, and take the filtrate to obtain the solution.

[0141] Determination method: Accurately pipette 1 μl of reference solution and test solution respectively, inject into liquid chromatograph, and determine. 16 H 18 O9) should be 0.30mg~1.20mg

[0142] Windproof

[0143]

Identification

[0144] Take 2g of this product, grind it, add 30ml of ethanol, ultrasonically treat it for 30 minutes, filter it, evaporate the filtrate, and add 1ml of ethanol to dissolve the residue as the test solution. Take another 0.5g of the Fangfeng reference medicinal material, add 30ml of ethanol, and make a reference medicinal material solution in the same way. Take the cimicifuga glycoside reference substance and the 5-O-methylvisamin alcohol glycoside reference substance, add ethanol to make a mixed solution containing 0.5mg per 1ml as the reference solution. According to the thin layer chromatography method (General Rules 0502 of the 2020 Edition of the Chinese Pharmacopoeia), 20μl of the Fangfeng reference medicinal material, 10μl of the test solution and the reference solution are taken, and they are respectively spotted on the same silica gel GF254 thin layer plate, with chloroform-methanol (4:1) as the developing agent, develop, take out, dry, and examine under ultraviolet light (254nm). In the chromatogram of the test product, spots of the same color appear at the corresponding positions of the chromatograms of the reference medicinal material and the reference substance.

[0145]

Content determination

[0146] Octadecylsilane bonded silica gel was used as filler (column length: 100 mm, inner diameter: 2.1 mm, particle size: 1.7 μm), acetonitrile was used as mobile phase A, water was used as mobile phase B, gradient elution was performed as specified in the following table, flow rate was 0.4 ml per minute, column temperature was 30°C, detection wavelength was 254 nm. The theoretical plate number calculated based on the cimicifuga glycoside peak should be no less than 20,000.

[0147]

[0148] Preparation of reference solution: Take appropriate amount of cimicifuga glycoside reference substance and 5-O-methylvisaminol glycoside reference substance, weigh accurately, add methanol to make a mixed solution containing 30 μg of each per 1 ml, shake well, and obtain.

[0149] Preparation of test solution: Take an appropriate amount of the product, grind it into powder, take about 0.1g, weigh it accurately, put it in a stoppered conical flask, add 10ml of methanol accurately, weigh it, treat it with ultrasound (power 250W, frequency 40kHz) for 30 minutes, let it cool, weigh it again, make up the lost weight with methanol, shake it well, filter it, and take the filtrate to obtain it.

[0150] Determination method: Accurately pipette 1 μl of reference solution and test solution respectively, inject into liquid chromatograph, and determine. 22 H 28 O 11 ) and 5-O-methylvisaminol glycoside (C 22 H 28 O 10 ) should be 6.0mg~16.0mg.

[0151] The therapeutic effect of the lung-clearing and detoxifying Chinese medicine formula for shortening fever and coughing time prepared in the embodiment and meeting the quality standards was tracked.

[0152] The patients who took the traditional Chinese medicine formula for clearing the lungs and detoxifying to shorten the duration of fever and cough were followed up on their medication through a questionnaire survey. The contents of the questionnaire survey are shown in Tables 1 and 2.

[0153] Table 1 Patient basic information collection form

[0154]

[0155]

[0156] Table 2 Statistical table of the efficacy of patients taking the traditional Chinese medicine formula for clearing lungs, detoxifying and relieving cough

[0157]

[0158] Statistics on basic information of patients enrolled in the lung-clearing and detoxifying traditional Chinese medicine formula that shortens the duration of fever and cough

[0159] A total of 91 case feedbacks were collected in the investigation of the efficacy of the Qingfei Jiedu Zhike Chinese medicine formula, of which 30 were used alone for traditional Chinese medicine, 24 were used alone for the Qingfei Jiedu Zhike Chinese medicine formula, and 37 were used for the Qingfei Jiedu Zhike Chinese medicine formula combined with Western medicine cold medicine. The basic statistics and grouping information of the patients are shown in Table 3. There was no significant difference in the basic conditions of the patients between the Qingfei Jiedu Zhike Chinese medicine formula group and the Qingfei Jiedu Zhike Chinese medicine formula combined with Western medicine cold medicine group (P>0.05).

[0160] Table 3 Basic information of patients in the traditional Chinese medicine, lung-clearing, detoxifying and cough-relieving Chinese medicine formula, and lung-clearing, detoxifying and cough-relieving Chinese medicine formula combined with Western cold medicine group

[0161]

[0162]

[0163] Observation on the therapeutic effect of traditional Chinese medicine formula for clearing lungs, detoxifying and relieving cough

[0164] Through the arrangement of the questionnaire, the improvement effect of the Chinese medicine formula for clearing lungs, detoxifying and relieving cough on cough, sore throat, fever, and difficulty in expectoration, as well as the incidence of adverse reactions, were statistically analyzed. The results were calculated using the chi-square test and one-way ANOVA, with a confidence interval of 95% and p < 0.05 for significant differences. The results found that:

[0165] ① The total effective rate of the antipyretic effect of the Qingfei Jiedu Zhike Chinese medicine formula was 70.80%, which was not significantly different from the cold medicine group combined with the traditional Chinese medicine and Qingfei Jiedu Zhike Chinese medicine formula (P>0.05); (Table 4)

[0166] ② The total effective rate of the Qingfei Jiedu Zhike Chinese medicine formula in improving throat pain was 77.80%, which was not significantly different from the traditional Chinese medicine and the Qingfei Jiedu Zhike Chinese medicine formula combined with the cold medicine group (P>0.05);

[0167] ③. The total effective rate of the Qingfei Jiedu Zhike Chinese medicine formula in improving the difficulty of expectoration was 95.20%, which was not significantly different from the cold medicine group combined with the traditional Chinese medicine and Qingfei Jiedu Zhike Chinese medicine formula (P>0.05);

[0168] ④. The total effective rate of the Qingfei Jiedu Zhike Chinese medicine formula in improving cough was 75.00%, which was not significantly different from the traditional Chinese medicine and Qingfei Jiedu Zhike Chinese medicine formula combined with cold medicine group (P>0.05);

[0169] ⑤. The average time required for fever reduction in the group of patients with the traditional Chinese medicine formula for clearing lungs, detoxifying and relieving cough was 21.50±13.53 hours, which was significantly different from that in the group with traditional Chinese medicine (P<0.05);

[0170] There was no significant difference compared with the group using the lung-clearing, detoxifying and cough-relieving Chinese medicine formula combined with cold medicine (P>0.05) (Table 5).

[0171] ⑥ The average time required for the patients in the lung-clearing, detoxifying and cough-relieving Chinese medicine group to relieve cough was 1.87±1.48 days, which was significantly different from that in the traditional Chinese medicine group (P<0.05);

[0172] Compared with the group of Chinese medicine formula for clearing lungs, detoxifying and relieving cough combined with cold medicine, there was a significant difference (P<0.05) (Table 6);

[0173] ⑦. There was no significant difference in the incidence of adverse reactions between the Qingfei Jiedu Zhike Chinese medicine formula group and the Qingfei Jiedu Zhike Chinese medicine formula combined with cold medicine group (P>0.05) (Table 7).

[0174] Table 4 Comparison of the efficacy of traditional Chinese medicine group, lung-clearing, detoxifying and cough-relieving Chinese medicine formula group and lung-clearing, detoxifying and cough-relieving Chinese medicine formula combined with cold medicine group

[0175]

[0176] Table 5 Comparison of fever reduction time in the traditional Chinese medicine group, the lung-clearing, detoxifying and cough-relieving Chinese medicine formula group, and the lung-clearing, detoxifying and cough-relieving Chinese medicine formula combined with cold medicine group, where returning to normal body temperature refers to no recurrence

[0177]

[0178] * Compared with the traditional Chinese medicine group, the time required to reduce fever by the lung-clearing, detoxifying and cough-relieving Chinese medicine formula was significantly reduced (P<0.05).

[0179] Table 6 Comparison of cough relief time in the traditional Chinese medicine group, the lung-clearing, detoxifying and cough-relieving Chinese medicine formula group, and the lung-clearing, detoxifying and cough-relieving Chinese medicine formula combined with cold medicine group

[0180]

[0181] * Compared with the traditional Chinese medicine group and the Qingfei Jiedu Zhike Chinese medicine formula combined with cold medicine group, the Qingfei Jiedu Zhike Chinese medicine formula group had a significantly shorter relief time (P<0.05);

[0182] Table 7 Comparison of the incidence of adverse reactions among traditional Chinese medicine group, lung-clearing, detoxifying and cough-relieving Chinese medicine formula group and lung-clearing, detoxifying and cough-relieving Chinese medicine formula combined with cold medicine group

[0183]

[0184] The results of this study showed that the clinical efficacy of the Chinese herbal formula for clearing the lungs, detoxifying and relieving cough in terms of cough relieving effect, cough relieving time, relieving throat pain, reducing fever, and relieving difficulty in expectoration was the same as that of traditional Chinese medicine and combined cold medicine, and the incidence of adverse reactions was not significant, proving that the Chinese herbal formula for clearing the lungs, detoxifying and relieving cough has a good therapeutic effect on cough and related symptoms caused by influenza.

[0185] At the same time, the Chinese medicine formula for clearing lungs, detoxifying and relieving cough is significantly better than traditional Chinese medicine in shortening the time required for fever and cough. The Chinese medicine formula for clearing lungs, detoxifying and relieving cough is modified from Ma Xing Gan Shi Tang, Zhi Cough Powder and Xiao Chai Hu Tang. Compared with traditional cough-relieving Chinese medicine, it not only relieves cough and resolves phlegm, but also highlights the effects of clearing lung heat and detoxification. In clinical application, it can not only relieve cough and resolve phlegm, relieve symptoms such as cough and sore throat, but also quickly relieve fever and cough.

[0186] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or replace some or all of the technical features therein with equivalents. However, these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A lung-clearing and detoxifying Chinese medicine for shortening the duration of fever and cough, characterized in that: Prepared from the following raw materials: 4-10 parts of roasted ephedra, 20-40 parts of gypsum, 10-20 parts of northern bupleurum, 5-15 parts of scutellaria, 10-20 parts of stir-fried atractylodes, 20-40 parts of verbena, 5-20 parts of patchouli, 4-10 parts of raw liquorice, 5-15 parts of white scutellaria, 5-15 parts of stemona, and 5-15 parts of siler.

2. A lung-clearing and detoxifying Chinese medicine for shortening the duration of fever and cough according to claim 1, characterized in that: Prepared from the following raw materials: 6 parts of roasted ephedra, 30 parts of gypsum, 15 parts of northern bupleurum, 10 parts of scutellaria, 15 parts of stir-fried atractylodes, 30 parts of verbena, 10 parts of patchouli, 6 parts of raw liquorice, 10 parts of white scutellaria, 10 parts of stemona, and 10 parts of siler.

3. The dosage form of a lung-clearing and detoxifying Chinese medicine for shortening the duration of fever and cough according to claim 1 or 2, characterized in that: The traditional Chinese medicine formula for clearing lungs, detoxifying and relieving cough is in the form of granules, decoctions, powders, pills, tablets, syrups, mixtures or oral liquids.

4. Use of a lung-clearing and detoxifying Chinese medicine for shortening fever and coughing time according to claim 1 or 2 in a medicine for shortening fever time.

5. Use of a lung-clearing and detoxifying Chinese medicine for shortening fever and coughing time according to claim 1 or 2 in a medicine for reducing coughing time.

Images