A traditional Chinese medicine composition for treating exogenous wind-heat in children and a preparation method thereof

Abstract

The application provides a traditional Chinese medicine composition for treating wind-heat syndrome in children and a preparation method thereof, and relates to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition for treating wind-heat syndrome in children comprises the following raw materials: mint, silkworm chrysalis, raw gypsum, anemarrhena, scutellaria, artemisia, figwort and psoralea. The traditional Chinese medicine composition can treat wind-heat syndrome in children, can significantly improve the clinical symptoms and signs of the children, and can improve the immunity of the children, and thus is high in effect and safety and worthy of clinical promotion and application.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine, in particular, relates to a traditional Chinese medicine composition for treating pediatric exogenous wind-heat and a preparation method thereof. BACKGROUND

[0002] Common cold, commonly known as cold, is an upper respiratory tract infectious inflammation caused by viruses or bacteria. It is highly contagious and can occur in all seasons, but is more common in winter and spring. According to traditional Chinese medicine, when the climate changes suddenly, the cold and heat are out of order, or when going out in the wind, the body's internal and external functions are weakened, and the wind-cold and wind-heat evils invade, the evil invades the lung and the defensive system, and the defensive system is not firm, resulting in disease. The main symptoms are fever, nasal congestion, runny nose, sore throat and headache, sometimes also with joint pain and general discomfort. Pediatric wind-heat cold is a common disease. Due to the special physiological and disease characteristics of children, the various pains and diseases of children have adverse effects on the body. Although most of the diseases of children are not difficult to diagnose clinically, the implementation of treatment is more difficult. There are many drug preparations for treating children's cold on the market, including western medicine and traditional Chinese medicine. Western medicine has large side effects, and traditional Chinese medicine has a more unpleasant odor. Children's bodies are relatively weak, so the efficacy of medication and the children's ability to withstand medication should be considered. Therefore, how to develop a traditional Chinese medicine composition with significant curative effect on children patients has become a realistic topic. SUMMARY

[0003] The purpose of the present application is to provide a traditional Chinese medicine composition for treating pediatric exogenous wind-heat, which has the advantage of significant curative effect on children patients.

[0004] Another purpose of the present application is to provide two preparation methods of the traditional Chinese medicine composition for treating pediatric exogenous wind-heat, in order to prepare the traditional Chinese medicine composition with significant curative effect.

[0005] To solve the above problems, the technical method adopted by the present application is:

[0006] On the one hand, the present application provides a traditional Chinese medicine composition for treating pediatric exogenous wind-heat, which comprises the following raw materials: mint, silkworm chrysalis, gypsum, anemarrhena, scutellaria, artemisia, figwort and psoralea.

[0007] On the other hand, the present application provides a preparation method of the traditional Chinese medicine composition for treating pediatric exogenous wind-heat, which comprises the following steps:

[0008] The raw materials are weighed and mixed to obtain a mixture 1;

[0009] The mixture 1 is immersed in water, soaked and decocted, and then the first filtrate and the filter residue are filtered out. The filter residue is mixed with water, decocted, and then the second filtrate is filtered out. The first filtrate and the second filtrate are combined to obtain an extract;

[0010] The extract is concentrated to obtain an extract;

[0011] The extract is mixed with excipients to form granules, and the granules are sieved to obtain the traditional Chinese medicine composition for treating infantile exogenous wind-heat.

[0012] In still another aspect, the application provides a preparation method of the traditional Chinese medicine composition for treating infantile exogenous wind-heat, comprising the following steps:

[0013] The raw materials are weighed and mixed to obtain a mixture 2;

[0014] The mixture 2 is immersed in water, heated to boiling, and filtered to obtain a decoction liquid and a decoction residue. The decoction residue is mixed with water, heated to reflux, and a reflux liquid is obtained. The decoction liquid and the reflux liquid are mixed, concentrated, and treated to obtain a concentrated liquid.

[0015] The concentrated liquid is spray-dried, mixed with excipients, and sieved to obtain the traditional Chinese medicine composition for treating infantile exogenous wind-heat.

[0016] Compared with the prior art, the application has at least the following advantages or beneficial effects:

[0017] The present inventors believe that infantile upper respiratory tract infection belongs to the category of "common cold" and "wind-evil" in traditional Chinese medicine. The lung governs the skin and hair, and the viscera of infants are tender. If the wind-heat evil or the wind-cold evil enters the interior and turns into heat, the defensive system and the lung will be out of balance, and the lung qi will be unable to be diffused, and then symptoms such as fever, nasal obstruction, runny nose, cough, headache, etc. will appear.

[0018] Based on the above reasons, the application selects peppermint, white muscardine and greenleaf worm for its clear and cool fragrance, which is good at dispelling evil from the defensive system. Gypsum fibrosum, anemarrhena and scrophularia are bitter and cold, which are good at clearing heat from the qi system. Combined with radix scrophulariae and psoralea, they nourish yin and generate fluid, clear away fire and detoxify, prevent high fever from damaging yin, and have the meaning of "keeping one part of fluid, there will be one part of life". In this way, the wind evil is dispelled, the heat and toxin are cleared, and the yin fluid is preserved, which can quickly reduce fever and make the patient recover. The combination of the drugs has the functions of dispersing wind and clearing heat, clearing away heat and detoxifying, and generating fluid and protecting yin, which can treat the same disease of the defensive system and the lung, and clear the exterior and the interior. It is mainly used for treating infantile exogenous wind-heat and the same disease of the defensive system and the lung. The symptoms include high fever that does not subside, with or without sweat, nasal obstruction, runny nose, red and swollen throat, yellow urine and dry stool, red tongue with thin white or yellowish fur, slippery and rapid pulse, and infantile upper respiratory tract infection with the above symptoms.

[0019] In summary, the traditional Chinese medicine composition of the application can treat infantile exogenous wind-heat, significantly improve the clinical symptoms and signs of the patient, and improve the immunity of the body. The effect is significant, the safety is high, and it is worthy of clinical popularization and application.

[0020] The application also provides a method for preparing the traditional Chinese medicine composition, which can maximize the extraction of beneficial substances from the raw materials, and efficiently and simply prepare the traditional Chinese medicine composition for batch production. DETAILED DESCRIPTION

[0021] In order to make the purposes, technical solutions and advantages of the embodiments of the present application clearer, the technical solutions in the embodiments of the present application will be clearly and completely described below. The specific conditions are not indicated in the embodiments, and the conventional conditions or the conditions recommended by the manufacturers are adopted. The reagents or instruments used are not indicated by the manufacturers, and are all conventional products that can be purchased in the market.

[0022] It should be noted that the embodiments in the present application and the features in the embodiments can be combined with each other without conflict. The present application will be described in detail below with reference to specific embodiments.

[0023] Mint: bitter, cool; lung, liver meridian. Has the effect of dispelling wind-heat, clearing and benefiting the eyes, benefiting the throat and penetrating rash, and soothing the liver and promoting qi. It is used to treat wind-heat cold, warm disease at the beginning, wind-heat headache, red eyes and tears, sore throat, measles not penetrating, wind rash and itching, and liver stagnation and chest tightness and hypochondriac pain.

[0024] Fried with bran: bitter, salty, and flat; liver, lung meridian. It has the effect of calming wind and stopping convulsion, expelling wind and relieving pain, and resolving phlegm and dispelling mass. It is used to treat convulsions caused by acute and chronic convulsions, epilepsy, tetanus, etc.; wind in the meridians, facial distortion; wind-heat headache, red eyes, sore throat, and wind rash and itching; scrofula and phlegm mass.

[0025] Gypsum fibrosum: bitter, warm; liver, spleen meridian. It has the effects of drying dampness, killing insects, stopping bleeding, pain, and eroding evil flesh. It is used to treat tinea, eczema, trauma, burns, hemorrhoids, prolapse of the anus, and warts. It is used to treat diarrhea and leucorrhea.

[0026] Anemarrhena: bitter, sweet, and cold; lung, stomach meridian. It has the effects of clearing heat and purging fire, and nourishing yin and moistening dryness. It is used to treat hot disease with thirst, lung heat with dry cough, bone steaming with hot flashes, internal heat with polydipsia, and dry constipation.

[0027] Scutellaria: bitter, cold; lung, gallbladder, and spleen meridian. It has the effects of clearing heat and drying dampness, purging fire and detoxifying, stopping bleeding, and calming the fetus. It is used to treat dampness-heat, summer dampness, chest tightness with vomiting, damp-heat distention, jaundice with diarrhea, lung heat with cough, high fever with polydipsia, blood heat with hematemesis, and fetal movement.

[0028] Artemisia: bitter, pungent, and cold; liver and gallbladder meridian. It has the effects of clearing and penetrating heat, cooling blood and removing heat, relieving summer heat, and stopping malaria. It is used to treat warm pathogen damaging yin, night heat and early cooling, yin deficiency with fever, labor heat with bone steaming, summer heat with external invasion, fever with polydipsia, and malaria with cold and heat.

[0029] Radix Scrophulariae: sweet, bitter, and salty, and slightly cold. It has the effects of clearing heat and cooling blood, purging fire and detoxifying, and nourishing yin. It is used to treat warm pathogen invading the nutrient QI, internal invasion of the heart and pericardium, warm toxin with rash, heat disease damaging yin, dryness with constipation, bone steaming with labor cough, red eyes with sore throat, scrofula, diphtheria, and abscesses and sores.

[0030] Lycium bark: sweet in taste and cold in nature; it enters the lung, liver, and kidney meridians. It has the effects of cooling the blood and relieving fever, clearing the lungs and reducing heat. It is mainly used to treat yin deficiency fever, night sweats and bone steaming, lung heat cough, and blood heat bleeding.

[0031] Burdock seed: It has the effects of dispersing wind-heat, clearing the lungs and resolving phlegm, relieving sore throat and promoting rash eruption, and detoxifying and reducing swelling. It is mainly used to treat wind-heat colds, the initial stage of febrile diseases, incomplete measles eruption, itchy rashes, carbuncles and boils, erysipelas, mumps and sore throat.

[0032] Reed rhizome: It has the effects of clearing heat and purging fire, promoting body fluid and quenching thirst, relieving irritability, stopping vomiting, and promoting urination. It is mainly used to treat feverish thirst, stomach heat vomiting, lung heat cough, lung abscess with purulent sputum, and painful urination due to heat.

[0033] This application provides a traditional Chinese medicine composition for treating exogenous wind-heat in children, characterized by comprising the following raw materials: peppermint, silkworm, gypsum, anemarrhena, scutellaria, artemisia, scrophularia and lycium bark.

[0034] This application selects peppermint, silkworm pupae, and artemisia annua, which have a fragrant and refreshing aroma, are light and cooling, and are good at dispelling pathogenic factors in the Wei level; gypsum, anemarrhena, and scutellaria are bitter, pungent, and cold, and are good at clearing heat in the Qi level; combined with scrophularia and lycium bark, they nourish Yin and generate fluids, clear heat and detoxify, and prevent high fever from damaging Yin, embodying the idea that "preserving a little body fluid means preserving a little life." In this way, wind-evil is dispelled, heat toxins are cleared, Yin fluids are preserved, and fever is quickly reduced, leading to the child's recovery. The combination of these herbs works together to dispel wind and heat, clear heat and detoxify, generate fluids and protect Yin, achieving the effect of treating both Wei and Qi, and clearing both the exterior and interior. It is mainly used to dispel wind and clear heat, detoxify and protect Yin, and is used to treat exogenous wind-heat in children with symptoms related to both Wei and Qi. Symptoms include persistent high fever, sweating or little sweating, nasal congestion and runny nose, red and swollen throat, yellow urine and dry stools, red tongue with a thin white or thin yellow coating, and a slippery and rapid pulse; these are also seen in children with upper respiratory tract infections exhibiting the above symptoms.

[0035] In some embodiments of this application, the above-mentioned traditional Chinese medicine composition comprises the following raw materials in parts by weight: 3-11 parts of peppermint, 3-11 parts of silkworm pupae, 15-25 parts of gypsum, 7-17 parts of anemarrhena asphodeloides, 7-17 parts of scutellaria baicalensis, 7-17 parts of artemisia annua, 7-17 parts of scrophularia ningpoensis, and 7-17 parts of lycium chinense root bark. Under this ratio, the obtained traditional Chinese medicine composition is most effective for treating infantile wind-heat colds.

[0036] In some embodiments of this application, the above-mentioned traditional Chinese medicine composition includes the following raw materials in parts by weight: 5-9 parts of peppermint, 5-9 parts of silkworm pupae, 18-24 parts of gypsum, 10-14 parts of anemarrhena asphodeloides, 10-14 parts of scutellaria baicalensis, 10-14 parts of artemisia annua, 10-14 parts of scrophularia ningpoensis, and 10-14 parts of lycium chinense root bark.

[0037] In some embodiments of this application, the aforementioned silkworm pupae are specifically stir-fried silkworm pupae with wheat bran. Ordinary silkworm pupae have a strong pungent and dispersing effect and are potent. However, after being stir-fried with wheat bran, their ability to dispel wind and release the exterior is slightly weakened, making them better at resolving phlegm and dissipating nodules. When combined with peppermint and artemisia annua, they are stronger in dispersing and clearing away pathogens in the Wei level.

[0038] The application further provides a preparation method of the traditional Chinese medicine composition for treating infantile exogenous wind-heat, comprising the following steps:

[0039] The raw materials are weighed and mixed to obtain a mixture 1;

[0040] The mixture 1 is immersed in water, soaked and decocted, and then the first filtrate and the filter residue are filtered out; the filter residue is mixed with water, decocted, and then the second filtrate is filtered out; the first filtrate and the second filtrate are combined to obtain an extract;

[0041] The extract is concentrated to obtain an extract powder;

[0042] The extract powder is sieved and mixed with excipients to prepare granules, thereby obtaining the traditional Chinese medicine composition for treating infantile exogenous wind-heat.

[0043] The raw materials are mixed and soaked, and then decocted twice, so that the beneficial substances in the raw materials can be fully extracted; then the extract is concentrated to obtain the finished product; the whole process is simple and convenient, and is suitable for batch production.

[0044] In some embodiments of the application, the mass ratio of the mixture 1 to water is 1: (10-15), the mixture 1 is soaked in water for 15-45 min, and then decocted for 30-90 min; the mass ratio of the filter residue to water is 1: (6-10), the filter residue is mixed with water and then decocted for 30-90 min; the concentration condition is that the extract is concentrated under the condition that the temperature is not more than 70 ℃ and the vacuum degree is-0.07 MPa, so as to obtain the extract powder with a relative density of 1.2-1.3; the excipient is dextrin, the mass ratio of the extract powder to the excipient is 1:3, and the granules are sieved through a 14-mesh sieve.

[0045] In some embodiments of the application, the mixing of the extract powder and dextrin is specifically that the dry air is heated to 60-70 ℃, and then enters the fluidized bed from the bottom of the fluidized bed for preheating for 30 min; then the extract powder is sieved through a 100-mesh sieve and mixed with dextrin to obtain the traditional Chinese medicine composition fine powder;

[0046] The hot air drives the traditional Chinese medicine composition fine powder to be in a fluidized state, and the water is atomized into small droplets and dispersed in the fluidized bed layer to collide with the traditional Chinese medicine composition fine powder to form granules; after the air continues to flow for 5-30 min, the granules are sieved through a 14-mesh sieve to obtain the traditional Chinese medicine composition for treating infantile exogenous wind-heat.

[0047] In some embodiments of the application, the mass ratio of water to the traditional Chinese medicine composition fine powder is 1:3, the flow rate of water is 5.4-21.6 g / min / kg, the water temperature is 25-55 ℃, the water atomization pressure is 1-2 bar, and the traditional Chinese medicine composition for treating infantile exogenous wind-heat has a water content of less than 9%.

[0048] The application further provides a preparation method of the traditional Chinese medicine composition for treating infantile exogenous wind-heat, comprising the following steps:

[0049] The raw materials are weighed and mixed to obtain mixture 2;

[0050] The mixture 2 is immersed in water, heated to boiling, and then filtered to obtain decoction liquid and decoction residue; the decoction residue is mixed with water, heated to reflux, and then reflux liquid is obtained; the decoction liquid and the reflux liquid are mixed, and concentrated to obtain concentrated liquid;

[0051] The concentrated liquid is spray-dried and sieved, and then mixed with auxiliary materials to obtain the traditional Chinese medicine composition for treating infantile exogenous wind-heat.

[0052] By immersing the raw materials in water and then heating to boiling and decoction, beneficial substances can be extracted; by refluxing the decoction residue, beneficial substances can be further extracted, so as to ensure sufficient extraction of the raw materials; by spray low-temperature drying, the product can be fully dried without loss of beneficial substances.

[0053] In some embodiments of the application, the mass ratio of the mixture 2 to water is 1: (10-15), the mixture 2 is boiled and decocted for 30-90 min after being mixed with water; the mass ratio of the decoction residue to water is 1: (6-10), the reflux treatment time is 30-90 min; the concentration treatment time is 2-3 h, and the relative density of the concentrated liquid is 1.2-1.3.

[0054] In some embodiments of the application, the spray drying conditions are that the inlet air temperature is lower than 70℃, the feeding flow rate is 1-1.6 kg / min, the auxiliary material is dextrin, the mass ratio of the spray-dried concentrated liquid to auxiliary material is 1:3, and the particles are sieved through a 14-mesh sieve.

[0055] The features and performances of the application are further described in detail in combination with the following embodiments.

[0056] Embodiment 1

[0057] A preparation method of a traditional Chinese medicine composition for treating infantile exogenous wind-heat, comprising the following steps:

[0058] Raw materials: 13 g of mint, 3 g of silkworm chrysalis, 15 g of raw gypsum, 5 g of anemarrhena, 10 g of scutellaria, 7 g of artemisia, 7 g of scrophularia, and 7 g of psoralea.

[0059] The raw materials are weighed and mixed to obtain mixture 1;

[0060] The mixture 1 is immersed in water at a mass ratio of 1:10, soaked for 15 min, and filtered to obtain a first filtrate and residue after decocting for 30 min. The residue is mixed with water at a mass ratio of 1:6, decocted for 30 min, and filtered to obtain a second filtrate. The first filtrate and the second filtrate are combined to obtain an extract;

[0061] The extract is concentrated under a temperature of not more than 70°C and a vacuum degree of -0.07 MPa to obtain an extract powder with a relative density of 1.2;

[0062] After the drying air is dried by a rotary dehumidifier, the dried air is heated to 60°C by a primary filter and a heater, and then enters a fluidized bed from the bottom of the fluidized bed for preheating for 30 min. After the extract powder is dried and passed through a 100-mesh sieve, the extract powder is mixed with a excipient (dextrin) at a mass ratio of 1:3 to obtain a traditional Chinese medicine composition fine powder;

[0063] The traditional Chinese medicine composition fine powder is driven by hot air in a fluidized state. Water is added at a mass ratio of 1:3 of the traditional Chinese medicine composition fine powder, and a peristaltic pump is used to deliver the water to a spray gun pipe. The water is atomized into small droplets by 1 bar of compressed air, and dispersed in the fluidized bed layer at a speed of 5.4 g / min / kg to collide with the traditional Chinese medicine composition fine powder to form particles. After the air is continuously introduced for 5 min, the particles are obtained, passed through a 14-mesh sieve, and a traditional Chinese medicine composition for treating infantile exogenous wind-heat (with a water content of less than 9%) is obtained.

[0064] Example 2

[0065] A preparation method of a traditional Chinese medicine composition for treating infantile exogenous wind-heat, comprising the following steps:

[0066] Raw materials: 3 g of mint, 3 g of silkworm chrysalis, 15 g of gypsum, 7 g of anemarrhena, 7 g of scutellaria, 7 g of radix codonopsis, and 7 g of cortex psoraleae.

[0067] The raw materials are weighed and mixed to obtain a mixture 1;

[0068] The mixture 1 is immersed in water at a mass ratio of 1:10, soaked for 15 min, and filtered to obtain a first filtrate and residue after decocting for 30 min. The residue is mixed with water at a mass ratio of 1:6, decocted for 30 min, and filtered to obtain a second filtrate. The first filtrate and the second filtrate are combined to obtain an extract;

[0069] The extract is concentrated under a temperature of not more than 70°C and a vacuum degree of -0.07 MPa to obtain an extract powder with a relative density of 1.2;

[0070] After drying the air by a rotary dehumidifier, the dried air is heated to 60°C by a primary filter and a heater, and then enters the fluidized bed from the bottom of the fluidized bed for preheating for 30 minutes. The extract is dried and passed through a 100-mesh sieve, and then mixed with the excipient (dextrin) at a mass ratio of 1:3 to obtain the fine powder of the traditional Chinese medicine composition;

[0071] The hot air drives the fine powder of the traditional Chinese medicine composition to be in a fluidized state. Water is added at a mass ratio of 1:3 to the fine powder of the traditional Chinese medicine composition, and a peristaltic pump is used to deliver the water to the spray gun pipe. Compressed air at 1 bar atomizes the water into small droplets, which are dispersed in the fluidized bed at a speed of 5.4 g / min / kg and collide with the fine powder of the traditional Chinese medicine composition to form particles. After the air is continuously supplied for 5 minutes, the particles are obtained, which are passed through a 14-mesh sieve to obtain the traditional Chinese medicine composition for treating infantile exogenous wind-heat (with a water content of less than 9%).

[0072] Example 3

[0073] A preparation method of a traditional Chinese medicine composition for treating infantile exogenous wind-heat includes the following steps:

[0074] Raw materials: 5 g of mint, 5 g of silkworm chrysalis, 18 g of raw gypsum, 10 g of anemarrhena, 10 g of scutellaria, 10 g of herba artemisiae, 10 g of radix scrophulariae, and 10 g of cortex lycii.

[0075] The raw materials are weighed and mixed to obtain a mixture 1;

[0076] The mixture 1 is immersed in water at a mass ratio of 1:13, soaked for 30 minutes, and then filtered to obtain a first filtrate and a filter residue. The filter residue is mixed with water at a mass ratio of 1:8, and then boiled for 60 minutes to obtain a second filtrate. The first filtrate and the second filtrate are combined to obtain an extract;

[0077] The extract is concentrated under the condition of a temperature of not more than 70°C and a vacuum degree of -0.07 MPa to obtain an extract with a relative density of 1.25;

[0078] After drying the air by a rotary dehumidifier, the dried air is heated to 65°C by a primary filter and a heater, and then enters the fluidized bed from the bottom of the fluidized bed for preheating for 30 minutes. The extract is dried and passed through a 100-mesh sieve, and then mixed with the excipient (dextrin) at a mass ratio of 1:3 to obtain the fine powder of the traditional Chinese medicine composition;

[0079] Hot air drives the fine powder of the traditional Chinese medicine composition into a fluidized state, water is added in a mass ratio of 1:3 with the fine powder of the traditional Chinese medicine composition, and a peristaltic pump is used to deliver the water to the spray gun pipe, 1.5 bar compressed air is used to atomize the water into small droplets, which are dispersed in the fluidized bed layer at a speed of 13 g / min / kg to collide with the fine powder of the traditional Chinese medicine composition to form particles, after 15 minutes of continuous air supply, the particles are formed, sieved through a 14 mesh sieve, and a traditional Chinese medicine composition for treating infantile exogenous wind-heat (with a water content of less than 9%) is obtained.

[0080] Example 4

[0081] A preparation method of a traditional Chinese medicine composition for treating infantile exogenous wind-heat, comprising the following steps:

[0082] Raw materials: 7g of mint, 7g of canary grass, 21g of gypsum, 12g of anemarrhena, 12g of scutellaria, 12g of radix et rhizoma encalypti, 12g of radix scrophulariae, and 12g of cortex lycii.

[0083] Weigh the raw materials and mix them to obtain mixture 1;

[0084] Soak mixture 1 in water in a mass ratio of 1:13, soak for 30 minutes, filter out the first filtrate and filter residue after decocting for 30 minutes, mix the filter residue with water in a mass ratio of 1:8, filter out the second filtrate after decocting for 60 minutes, and combine the first filtrate and the second filtrate to obtain an extract;

[0085] Concentrate the extract under the condition of a temperature not exceeding 70°C and a vacuum degree of-0.07MPa to obtain an extract powder with a relative density of 1.25;

[0086] After the drying air is dehumidified by a rotary dehumidifier, the dried air is heated to 65°C by a primary filter and a heater, and then enters the fluidized bed from the bottom of the fluidized bed to preheat for 30 minutes, and then the extract powder is dried and sieved through a 100 mesh sieve, and then mixed with excipients (dextrin) in a mass ratio of 1:3 to obtain a fine powder of the traditional Chinese medicine composition;

[0087] Hot air drives the fine powder of the traditional Chinese medicine composition into a fluidized state, water is added in a mass ratio of 1:3 with the fine powder of the traditional Chinese medicine composition, and a peristaltic pump is used to deliver the water to the spray gun pipe, 1.5 bar compressed air is used to atomize the water into small droplets, which are dispersed in the fluidized bed layer at a speed of 13 g / min / kg to collide with the fine powder of the traditional Chinese medicine composition to form particles, after 15 minutes of continuous air supply, the particles are formed, sieved through a 14 mesh sieve, and a traditional Chinese medicine composition for treating infantile exogenous wind-heat (with a water content of less than 9%) is obtained.

[0088] Example 5

[0089] A preparation method of a traditional Chinese medicine composition for treating infantile exogenous wind-heat, comprising the following steps:

[0090] Ingredients: mint 9g, canary 9g, raw gypsum 24g, Anemarrhena 14g, Scutellaria 14g, green wormwood 14g, figwort 14g and ground cork 14g.

[0091] Weigh the ingredients and mix them to obtain mixture 1;

[0092] Submerge mixture 1 in water at a mass ratio of 1:13, soak for 30 minutes, filter out the first filtrate and residue after decocting for 30 minutes, mix the residue with water at a mass ratio of 1:8, filter out the second filtrate after decocting for 60 minutes, combine the first filtrate and the second filtrate to obtain the extract;

[0093] Concentrate the extract under the condition of a temperature not exceeding 70℃ and a vacuum degree of -0.07MPa to obtain the extract residue with a relative density of 1.25;

[0094] After the drying air is dehumidified by a rotary dehumidifier, the dried incoming air is heated to 65℃ by a primary filter and a heater, and then enters the fluidized bed from the bottom of the fluidized bed to be preheated for 30 minutes. After the extract residue is dried and passed through a 100-mesh sieve, it is mixed with the excipient (dextrin) at a mass ratio of 1:3 to obtain the fine powder of the traditional Chinese medicine composition;

[0095] The hot air drives the fine powder of the traditional Chinese medicine composition to be fluidized, water is added at a mass ratio of 1:3 with the fine powder of the traditional Chinese medicine composition, and a peristaltic pump is used to deliver the water to the spray gun pipe. The water is atomized into small droplets by compressed air at 1.5bar, and dispersed in the fluidized bed layer at a speed of 13g / min / kg to collide with the fine powder of the traditional Chinese medicine composition to form particles. After the incoming air continues for 15 minutes, the granules are prepared and passed through a 14-mesh sieve to obtain the traditional Chinese medicine composition for treating infantile exogenous wind-heat (with a water content of less than 9%).

[0096] Example 6

[0097] A preparation method of a traditional Chinese medicine composition for treating infantile exogenous wind-heat, comprising the following steps:

[0098] Ingredients: mint 11g, canary 11g, raw gypsum 25g, Anemarrhena 17g, Scutellaria 17g, green wormwood 17g, figwort 17g and ground cork 17g.

[0099] Weigh the ingredients and mix them to obtain mixture 1;

[0100] Submerge mixture 1 in water at a mass ratio of 1:15, soak for 45 minutes, filter out the first filtrate and residue after decocting for 90 minutes, mix the residue with water at a mass ratio of 1:10, filter out the second filtrate after decocting for 90 minutes, combine the first filtrate and the second filtrate to obtain the extract;

[0101] The extract is concentrated under the condition of temperature not more than 70℃ and vacuum degree -0.07MPa, to obtain the extract with relative density 1.3;

[0102] After the air is dried by the rotary dehumidifier, the dried air is heated to 70℃ by the primary filter and the heater, and then enters the fluidized bed from the bottom of the fluidized bed for preheating for 30min. Then the extract is dried and passed through a 100 mesh sieve, and mixed with the excipient (dextrin) according to the mass ratio of 1:3 to obtain the fine powder of the traditional Chinese medicine composition;

[0103] The hot air drives the fine powder of the traditional Chinese medicine composition to be in a fluidized state. Water is added according to the mass ratio of 1:3 of the fine powder of the traditional Chinese medicine composition, and the water is delivered to the spray gun pipe by using a peristaltic pump. The water is atomized into small droplets by 2bar compressed air, and dispersed in the fluidized bed layer at a speed of 21.6g / min / kg to collide with the fine powder of the traditional Chinese medicine composition to form particles. After the air is continuously introduced for 30min, the particles are prepared, passed through a 14 mesh sieve, and the traditional Chinese medicine composition for treating infantile exogenous wind-heat (with water content less than 9%) is obtained.

[0104] Example 7

[0105] This example is basically the same as Example 3, except that the preparation method is different.

[0106] A preparation method of a traditional Chinese medicine composition for treating infantile exogenous wind-heat, comprising the following steps:

[0107] Raw materials: 5g of mint, 5g of silkworm chrysalis, 18g of gypsum, 10g of anemarrhena, 10g of scutellaria, 10g of herba artemisiae, 10g of radix scrophulariae, and 10g of cortex lycii.

[0108] The raw materials are weighed and mixed to obtain mixture 2;

[0109] Mixture 2 is immersed in water according to the mass ratio of 1:10, and heated to boiling. After 30min of boiling, the decoction liquid and the decoction residue are filtered. The decoction residue is mixed with water according to the mass ratio of 1:6, and heated to reflux state for 30min to obtain the reflux liquid. The decoction liquid and the reflux liquid are mixed, and concentrated for 2h to obtain the concentrated liquid with relative density 1.2;

[0110] The concentrated liquid is spray dried under the condition of air inlet temperature lower than 70℃ and material inlet flow rate of 1kg / min. Then the traditional Chinese medicine composition for treating infantile exogenous wind-heat is obtained by mixing the spray dried concentrated liquid with the excipient (dextrin) according to the mass ratio of 1:3, and passing through a 14 mesh sieve.

[0111] Example 8

[0112] This example is basically the same as Example 4, except that the preparation method is different.

[0113] A preparation method of a traditional Chinese medicine composition for treating exogenous wind-heat in children, comprising the following steps:

[0114] Raw materials: Mentha haplocalyx 7g, Bombyx Batryticatus 7g, Gypsum Fibrosum 21g, Anemarrhena Asphodeloides 12g, Scutellaria Baicalensis 12g, Artemisia Argyi 12g, Scrophularia Ningpoensis 12g and Psoralea Corylifolia 12g.

[0115] The raw materials are weighed and mixed to obtain mixture 2;

[0116] Mixture 2 is immersed in water according to a mass ratio of 1:13, heated to boiling, and boiled for 60 min; the decocting liquid and decocting residue are filtered; the decocting residue is mixed with water according to a mass ratio of 1:8, heated to refluxing, and kept for 60 min to obtain a refluxing liquid; the decocting liquid and the refluxing liquid are mixed and concentrated for 2.5h to obtain a concentrated liquid with a relative density of 1.25;

[0117] The concentrated liquid is spray-dried under the condition that the inlet air temperature is lower than 70℃ and the inlet flow rate is 1.3kg / min; then the spray-dried product is mixed with auxiliary materials (dextrin) according to a mass ratio of 1:3, and sieved through a 14-mesh screen to obtain the traditional Chinese medicine composition for treating exogenous wind-heat in children.

[0118] Example 9

[0119] This example is basically the same as example 5, except that the preparation method is different.

[0120] A preparation method of a traditional Chinese medicine composition for treating exogenous wind-heat in children, comprising the following steps:

[0121] Raw materials: Mentha haplocalyx 9g, Bombyx Batryticatus 9g, Gypsum Fibrosum 24g, Anemarrhena Asphodeloides 14g, Scutellaria Baicalensis 14g, Artemisia Argyi 14g, Scrophularia Ningpoensis 14g and Psoralea Corylifolia 14g.

[0122] The raw materials are weighed and mixed to obtain mixture 2;

[0123] Mixture 2 is immersed in water according to a mass ratio of 1:15, heated to boiling, and boiled for 90 min; the decocting liquid and decocting residue are filtered; the decocting residue is mixed with water according to a mass ratio of 1:10, heated to refluxing, and kept for 90 min to obtain a refluxing liquid; the decocting liquid and the refluxing liquid are mixed and concentrated for 3h to obtain a concentrated liquid with a relative density of 1.3;

[0124] The concentrated liquid is spray-dried under the condition that the inlet air temperature is lower than 70℃ and the inlet flow rate is 1.6kg / min; then the spray-dried product is mixed with auxiliary materials (dextrin) according to a mass ratio of 1:3, and sieved through a 14-mesh screen to obtain the traditional Chinese medicine composition for treating exogenous wind-heat in children.

[0125] Comparative Example 1

[0126] This comparative example is basically the same as Example 4, except that Scrophularia ningpoensis is replaced by Phragmites communis.

[0127] Comparative Example 2

[0128] This comparative example is basically the same as Example 4, except that Mentha haplocalyx is replaced by Arctium lappa.

[0129] Test Example

[0130] (1) Materials: 168 pediatric patients were randomly divided into 4 groups. The treatment group (n = 42) included 23 males and 19 females, aged 3-10 years, with a disease duration of 14-36 h; the control 1 group (n = 42) included 20 males and 22 females, aged 3-7 years, with a disease duration of 15-37 h; the control 2 group (n = 42) included 21 males and 21 females, aged 3-8 years, with a disease duration of 14-37 h; and the control 3 group (n = 42) included 19 males and 23 females, aged 3-9 years, with a disease duration of 15-37 h. The gender, age, and disease duration of the children in the four groups had no statistically significant differences (P > 0.05) and were comparable;

[0131] (2) Diagnostic criteria: Referring to the diagnostic criteria for wind-heat invading the exterior syndrome in the pediatric section of the Standard for Diagnosis and Treatment of TCM Syndromes, the patient had severe fever, mild chill, with or without sweating, headache, nasal obstruction with thick nasal discharge, cough, red throat, or red eyes with tearing, and thirst. The tongue was red and dry, with thin yellow fur and a floating and irregular pulse. The clinical manifestations included fever, nasal obstruction, nasal discharge, sore throat, diarrhea, headache, and fatigue;

[0132] (3) Treatment method: The patients in the control 1 group were given commercially available Xiao'er Chiqiao Qingre Granules (JiChuan Pharmaceutical Group Co., Ltd., product batch number 2203094, specification 2 g * 6 bags / box) to be taken with warm water; the patients in the control 2 group were given the traditional Chinese medicine composition prepared in Comparative Example 1 for treatment; the patients in the control 3 group were given the traditional Chinese medicine composition prepared in Comparative Example 1 for treatment; and the patients in the treatment group were given the traditional Chinese medicine composition prepared in Example 4 for treatment. The patients took the medicine after meals, avoided cooling, maintained regular sleep, and ate a light diet. Children under 3 years of age took 2 g each time, 3 times a day; children aged 3-7 years took 3 g each time, 3 times a day; and one week was a course of treatment. The recovery of the patients was observed every day;

[0133] (4) Evaluation index: The treatment of the patients in the four groups was observed, and the disappearance times of fever, cough, sore throat, and nasal obstruction and nasal discharge were recorded. The occurrence of adverse reactions such as nausea, vomiting, and diarrhea during the administration of the medicine was also observed. The treatment is shown in Table 1.

[0134] (5) Data processing method: SPSS22.0 software was used to analyze the data. Measurement data was expressed as x ± s, t test was used, count data was expressed as percentage, x^2 test was used. P<0.05 indicates that the difference is statistically significant;

[0135] (6) Results: The total effective rate of control group 1 was 83.33% (35 / 42), the total effective rate of control group 2 was 85.71% (36 / 42), the total effective rate of control group 3 was 83.33% (35 / 42), and the total effective rate of the treatment group was 95.24% (40 / 42). There was a significant difference (P<0.05) among the four groups, as shown in Table 2.

[0136] Table 1 Comparison of disappearance time of clinical symptoms and signs of two groups d)

[0137]

[0138] Note: Compared with the control group, *P<0.05, **P<0.01.

[0139] Table 2 Comparison of clinical efficacy of two groups

[0140]

[0141]

[0142] Note: Compared with the control group, *P<0.05.

[0143] Observing Table 1, compared with control groups 1-3, the treatment group has obvious effects on the subsidence of fever, cough, throat redness and swelling, and nasal congestion and runny nose, and has very obvious therapeutic effects on cough, throat redness and swelling, and nasal congestion and runny nose.

[0144] Observing Table 2, the number of ineffective people in the treatment group is only 2, while the number of ineffective people in control group 1 is 12; the cure, marked effect, effective and total effective rates of the treatment group are better than those of the control group; and compared with control groups 2-3, radix scrophulariae and rhizoma phragmitis have the effect of clearing heat and purging fire, and fructus arctii and mentha have the effect of dispelling wind and heat, and the therapeutic effect of the traditional Chinese medicine composition obtained by replacing the medicinal materials with similar efficacy is not as good as before. It can be seen that replacing the raw materials in the formula of the application with medicinal materials with similar efficacy will affect the efficacy, and the compatibility scheme of the application is feasible and has outstanding effects.

[0145] In summary, the researchers of the application believe that pediatric upper respiratory tract infection belongs to the category of "cold" and "wind" in traditional Chinese medicine. The lung governs the skin and hair, and the viscera of children are delicate, and the lung defense function is insufficient. If affected by wind-heat evil or wind-cold evil into heat, the defensive system and the upper jiao lung system will be out of balance, and the lung qi will be lost, and symptoms such as fever, nasal congestion, runny nose, cough, headache, etc. will appear.

[0146] For the above reasons, the application selects peppermint, white muscardine and sweet wormwood with the smell of Qingfang, which is light and cool, and is good at dispelling pathogenic factors from defensive Qifen; gypsum fibrosum, anemarrhena and scutellaria are bitter and cold, which are good at clearing heat from Qifen; combined with radix scrophulariae and psoralea corylifolia, they nourish Yin and produce fluid, clear away heat and detoxify, prevent high fever from damaging Yin, and have the meaning of "a drop of fluid can have a drop of life". In this way, the wind pathogen is dispelled, the heat and toxin are cleared, the Yin fluid is stored, and the fever is quickly reduced, so that the sick child recovers. The combination of various drugs can clear wind and dispel heat, clear heat and detoxify, and produce fluid and protect Yin, and has the effects of treating defensive Qifen and clearing the interior and exterior, and is used for treating children with exogenous wind-heat and defensive Qifen. Symptoms include high fever that does not subside, with or without sweating, nasal congestion and runny nose, red and swollen throat, yellow urine and dry stool, red tongue with thin white or yellowish fur, slippery and rapid pulse, and upper respiratory tract infection in children with the above symptoms.

[0147] In summary, the traditional Chinese medicine composition of the application can treat children with exogenous wind-heat invading the exterior, significantly improve the clinical symptoms and signs of the child, and improve the body's immunity, with significant effect and high safety, and is worthy of clinical application.

[0148] The application also provides a method for preparing the traditional Chinese medicine composition, which can maximize the extraction of beneficial substances from the raw materials, and efficiently and simply prepare the traditional Chinese medicine composition, which is convenient for batch production.

[0149] The above-described embodiments are part of the embodiments of the application, rather than all the embodiments. The detailed description of the embodiments of the application is not intended to limit the scope of the claimed application, but only represents selected embodiments of the application. Based on the embodiments in the application, all other embodiments obtained by those of ordinary skill in the art without creative labor fall within the scope of protection of the application.

Claims

1. A traditional Chinese medicine composition for treating exogenous wind-heat in children, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in mass parts: 3-11 parts of mint, 3-11 parts of canabis, 15-25 parts of raw gypsum, 7-17 parts of anemarrhena, 7-17 parts of scutellaria, 7-17 parts of radix scrophulariae, and 7-17 parts of cortex lycii.

2. The Chinese medicine composition for treating exogenous wind-heat in children according to claim 1, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in mass parts: 5-9 parts of mint, 5-9 parts of canabis, 18-24 parts of raw gypsum, 10-14 parts of anemarrhena, 10-14 parts of scutellaria, 10-14 parts of radix scrophulariae, and 10-14 parts of cortex lycii.

3. The Chinese medicine composition for treating exogenous wind-heat in children according to claim 1, characterized in that, The canabis is specifically wheat-fried canabis.

4. The preparation method of the traditional Chinese medicine composition for treating exogenous wind-heat in children according to any one of claims 1-3, characterized in that, The method comprises the following steps: The raw materials are weighed and mixed to obtain a mixture 1; The mixture 1 is immersed in water, soaked and decocted, and then the first filtrate and the filter residue are filtered out; the filter residue is mixed with water, decocted, and then the second filtrate is filtered out; the first filtrate and the second filtrate are combined to obtain an extract; The extract is concentrated to obtain an extractum; The extractum is sieved and mixed with excipients to prepare granules, thereby obtaining the traditional Chinese medicine composition for treating infantile exogenous wind-heat.

5. The preparation method of the traditional Chinese medicine composition for treating exogenous wind-heat in children according to claim 4, characterized in that, The mass ratio of the mixture 1 to water is 1: (10-15), the mixture 1 is soaked in water for 15-45 min and then decocted for 30-90 min; the mass ratio of the filter residue to water is 1: (6-10), the filter residue is mixed with water and then decocted for 30-90 min; the concentration condition is that the extract is concentrated under the condition that the temperature is not more than 70 ℃ and the vacuum degree is-0.07 MPa, thereby obtaining the extractum with a relative density of 1.2-1.3; the excipients are dextrin, the mass ratio of the extractum to the excipients is 1:3, and the granules are sieved through a 14-mesh sieve.

6. The preparation method of the traditional Chinese medicine composition for treating exogenous wind-heat in children according to claim 5, characterized in that, The mixture of the extractum and dextrin is specifically that the dry inlet air is heated to 60-70 ℃, enters a fluidized bed from the bottom of the fluidized bed to be preheated for 30 min to form hot air, the extractum is sieved through a 100-mesh sieve, and then mixed with dextrin to obtain a traditional Chinese medicine composition powder; The hot air drives the traditional Chinese medicine composition powder to be in a fluidized state, water is added and delivered to a spray gun pipe by using a peristaltic pump, the water is atomized into small droplets by compressed air, and the small droplets are dispersed in the fluidized bed layer to collide with the traditional Chinese medicine composition powder to form granules; after the inlet air continues to flow for 5-30 min, the granules are sieved through a 14-mesh sieve to obtain the traditional Chinese medicine composition for treating infantile exogenous wind-heat; The mass ratio of the water to the traditional Chinese medicine composition powder is 1:3, the flow rate of the water is 5.4-21.6 g / min / kg, the water temperature is 25-55 ℃, the water atomization pressure is 1-2 bar, and the traditional Chinese medicine composition for treating infantile exogenous wind-heat has a water content of less than 9%.

7. A method for preparing the Chinese medicinal composition for treating exogenous wind-heat in children according to any one of claims 1-3, characterized in that, The method comprises the following steps: The raw materials are weighed and mixed to obtain a mixture 2; The mixture 2 is immersed in water, heated to boiling, and then filtered to obtain a decocting liquid and a decocting residue; the decocting residue is mixed with water, heated to reflux, and then a reflux liquid is obtained; the decocting liquid and the reflux liquid are mixed and concentrated to obtain a concentrated liquid; The concentrated liquid is spray-dried to prepare granules, which are then mixed with excipients and sieved to obtain the traditional Chinese medicine composition for treating infantile exogenous wind-heat.

8. The preparation method of the traditional Chinese medicine composition for treating exogenous wind-heat in children according to claim 7, characterized in that, The mass ratio of the mixture 2 to water is 1: (10-15), the mixture 2 is boiled with water for 30-90 min after mixing; the mass ratio of the boiled residue to water is 1: (6-10), the reflux treatment time is 30-90 min; the concentration treatment time is 2-3 h, and the relative density of the concentrated liquid is 1.2-1.

3.

9. A method for preparing a traditional Chinese medicine composition for treating exogenous wind-heat syndrome in children according to claim 7, characterized in that, The spray drying conditions are that the inlet air temperature is lower than 70℃, the feed flow rate is 1-1.6 kg / min, the auxiliary material is dextrin, the mass ratio of the concentrated liquid to the auxiliary material after spray drying is 1:3, and the particles are passed through a 14-mesh sieve.

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