Traditional Chinese medicine composition for treating infantile pneumonia dyspnea and cough as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention relates to the technical field of traditional Chinese medicine, in particular to a traditional Chinese medicine composition for treating infantile pneumonia dyspnea and cough and a preparation method and application thereof. The traditional Chinese medicine composition is prepared from honey-fried ephedra, gypsum, semen armeniacae amarae, rhizoma belamcandae, houttuynia cordata, honeysuckle, cortex trichosanthis, lumbricus, radix salviae miltiorrhizae and liquorice, and medicines such as semen raphani, thunberg fritillary bulb, fructus perillae, semen lepidii and flos magnoliae can be selectively added according to diagnosis and examination results of individual cases. The traditional Chinese medicine composition has the effects of opening and closing the lung, clearing heat and eliminating phlegm. The traditional Chinese medicine is used for treating wind-heat closed lung, phlegm-heat closed lung and the like of infantile pneumonia dyspnea and cough; the symptoms include cough, expectoration, phlegm tusking, asthma, fever, and middle and fine wet rale in the lung. The traditional Chinese medicine composition can be used as or used for preparing medicines for treating infantile pneumonia dyspnea and cough.

Description

Technical Field

[0001] The invention relates to the technical field of traditional Chinese medicines, and in particular to a traditional Chinese medicine composition for treating pneumonia and asthma in children, and a preparation method and application thereof. Background Art

[0002] Pneumonia and wheezing in children is a common lung disease in pediatrics, which seriously threatens the health of children and is listed by the Ministry of Health of my country as one of the four diseases that need to be focused on prevention and treatment in children. The main clinical symptoms of this disease are fever, cough, sputum congestion, shortness of breath, and nasal flaring. At present, Western medicine treatment of pneumonia and wheezing in children usually focuses on pathogen treatment and symptomatic supportive treatment. Among them, pathogen treatment includes antiviral and antibacterial treatment, but pathogen treatment often has certain limitations and side effects. First of all, the equipment, technology and inspection time used by different medical institutions to examine pathogens are not the same, and there is a certain lag in the inspection results. Therefore, the use of drugs in the early stage of treatment still depends on the experience of clinicians. In addition, antibiotic treatment is currently the most commonly used pathogen treatment method in clinical practice. Its long-term use may cause children to develop drug resistance and reduce the body's immunity.

[0003] Traditional Chinese medicine has rich clinical experience in treating pneumonia and cough in children, and has significant characteristics and comparative advantages. Traditional Chinese medicine focuses on syndrome differentiation and treatment and holistic concepts in treating diseases. First of all, traditional Chinese medicine treatment will not affect the timely treatment of pneumonia and cough due to delayed etiological diagnosis. Secondly, while treating, it can also protect the child's physique. Furthermore, traditional Chinese medicine treatment has the characteristics of "simple, convenient, effective, and inexpensive", which are more easily accepted by children and parents. At present, some Chinese patent medicines that have been listed have good clinical efficacy in treating pneumonia and cough in children, but in the face of complex syndromes, they cannot fully meet clinical needs. Therefore, starting from the theory of traditional Chinese medicine, and taking into account the regional differences between the north and the south and the characteristics of physical fitness, it is an urgent problem for technical personnel in this field to provide a Chinese medicine composition that is more suitable for the southern region for the treatment of pneumonia and cough in children, and has clear effects and no obvious adverse reactions. Summary of the invention

[0004] In order to solve the above technical problems existing in the prior art, the present invention provides a Chinese medicine composition for treating pneumonia and asthma in children, and its preparation method and application. Specifically, it is achieved through the following technical solutions:

[0005] A Chinese medicine composition for treating pneumonia and cough in children comprises the following raw materials: roasted ephedra, gypsum, bitter almond, belamcanda, houttuynia cordata, honeysuckle, guawei peel, earthworm, salvia miltiorrhiza and liquorice.

[0006] Further, the weight proportions of the raw materials are: 2-10 parts of roasted ephedra, 10-60 parts of gypsum, 5-15 parts of bitter almonds, 3-15 parts of belamcanda, 3-25 parts of houttuynia, 3-15 parts of honeysuckle, 3-15 parts of guawei peel, 3-15 parts of earthworms, 3-15 parts of salvia miltiorrhiza, and 2-15 parts of liquorice. Preferably, the weight proportions of the raw materials are: 5 parts of roasted ephedra, 20 parts of gypsum, 6 parts of bitter almonds, 6 parts of belamcanda, 10 parts of houttuynia, 10 parts of honeysuckle, 8 parts of trichosanthes peel, 6 parts of earthworms, 8 parts of salvia miltiorrhiza, and 6 parts of liquorice.

[0007] Furthermore, personalized treatment can be carried out according to the diagnosis and examination results of individual cases, and other drugs can be selectively added to adjust the effect in a targeted manner. Other drugs that can be added include one or more of radish seeds, Fritillaria thunbergii, Perilla seeds, Lemongrass seeds, and Magnolia officinalis.

[0008] Further, the weight proportions of the raw materials can be adjusted according to the following proportions: 2-10 parts of roasted ephedra, 10-60 parts of gypsum, 5-15 parts of bitter almonds, 3-15 parts of belamcanda chinensis, 3-25 parts of houttuynia cordata, 3-15 parts of honeysuckle, 3-15 parts of cucurbitacin peel, 3-15 parts of earthworms, 3-15 parts of salvia miltiorrhiza, 3-15 parts of radish seeds, 3-15 parts of thunbergii bulbs, 3-15 parts of perilla seeds, 3-15 parts of scutellaria baicalensis seeds, 3-15 parts of magnolia buds, and 2-15 parts of licorice.

[0009] The Chinese medicine composition of the present application has the effects of promoting lung function, opening and closing, clearing away heat and resolving phlegm. It is used for wind-heat blocking the lungs and phlegm-heat blocking the lungs in children with pneumonia, wheezing and coughing; symptoms include coughing, expectoration, wheezing, fever, and medium and fine wet rales in the lungs. It is foreseeable that it will have good application prospects when used as or in the preparation of a drug for treating pneumonia, wheezing and coughing in children.

[0010] The above-mentioned Chinese medicine composition can be added with auxiliary materials to prepare a mixture or oral liquid. Each 1 ml of the mixture or oral liquid is equivalent to about 1.4 g of the decoction piece.

[0011] The mixture or oral liquid is prepared by the following method: the Chinese herbal medicine slices and gypsum are decocted in water for 30 minutes, and then the remaining nine herbs such as roasted ephedra are added, decocted twice, each time for 1 hour, filtered, combined filtrates, concentrated to a suitable relative density, allowed to stand, stevioside and sodium benzoate are added to the filtrate, water is added to adjust the total amount, stirred evenly, filtered, filled, sterilized, and the mixture or oral liquid is obtained.

[0012] The Chinese medicine composition can be used to prepare a decoction. Furthermore, the prepared decoction is obtained by decocting the Chinese medicine pieces with water.

[0013] The pharmaceutically acceptable excipients mentioned in the present invention include the excipients listed in the Handbook of Pharmaceutical Excipients (American Pharmaceutical Association, October 1986), the Handbook of Pharmaceutical Excipients (Original Fourth Edition) published by Chemical Industry Press, or the Complete Collection of Pharmaceutical Excipients (Sichuan Publishing Group, Sichuan Science and Technology Press, January 2006), but are not limited to these excipients.

[0014] This prescription is formulated based on the physiological and pathological characteristics of children and combined with many years of clinical experience. It is used to treat the early and extreme stages of pneumonia in children caused by different pathogens. The prescription is added or subtracted according to the accompanying symptoms of the child and the attenuation of the disease during the course of the disease. After preliminary observation, it is safe and effective in clinical application, especially in terms of expectoration and cough relief, and promoting the absorption of lung rales. However, pneumonia is an acute febrile disease in children, and the extreme stage is relatively short. This prescription mainly targets the basic pathogenesis of lung qi stagnation in pneumonia and performs the function of opening and closing the lungs. If the fever has subsided after taking the medicine, and the wheezing and cough have decreased, Xiebai Erchen Decoction can be used instead to clear the residual heat and resolve phlegm and benefit the lungs.

[0015] The roasted ephedra in the prescription is the dried herbaceous stem of Ephedra sinica Stapf, Ephedra intermedia Schrenk et CAmey. or Ephedra equisetina Bge. of the Ephedraceae family. It tastes spicy and slightly bitter, and is warm in nature. It enters the lung and bladder meridians. It has the effects of sweating and dispelling cold, clearing the lungs and relieving asthma, and promoting diuresis and reducing swelling. It is used for colds caused by wind and cold, chest tightness, coughing and wheezing, and edema caused by wind and water. It is mostly used for asthma and cough after the symptoms of the exterior have been resolved. Modern pharmacological studies have shown that ephedra has anti-inflammatory, antiviral, antipyretic, expectorant, sweating, and asthma-relieving effects.

[0016] The gypsum in the prescription is a sulfate mineral gypsum family gypsum, which mainly contains hydrous calcium sulfate. After mining, the miscellaneous stones and mud are removed. It tastes sweet and spicy, and is very cold in nature. It enters the lung and stomach meridians. It has the effects of clearing away heat and purging fire, relieving restlessness and quenching thirst. It is used for exogenous febrile diseases, high fever and thirst, lung heat and cough, etc. Modern pharmacological studies have shown that gypsum has the effects of reducing capillary permeability, enhancing macrophage phagocytosis, anti-virus, anti-inflammatory and immune promotion.

[0017] The bitter almond in the prescription is the dried mature seeds of Prunus armeniaca L.var.ansu Maxim., Prunus sibirica L., Prunus mandshurica (Maxim.) Koehne or Prunus armeniaca L. of the Rosaceae family. It tastes bitter, is slightly warm in nature and slightly toxic. It enters the lung and large intestine meridians. It has the effects of lowering qi, relieving cough and asthma, and moistening the intestines and relieving constipation. It is used for cough and asthma, chest fullness and phlegm, and constipation caused by dry intestines. Modern pharmacological studies have shown that bitter almonds have the effects of relieving cough and asthma, anti-inflammatory and analgesic, anti-tumor, anti-fibrosis, immune regulation, lowering blood lipids, and anti-atherosclerosis.

[0018] The herb in the prescription is the dried rhizome of Belamcanda chinensis (L.) DC. of the Iridaceae family. It tastes bitter and is cold in nature. It enters the lung meridian. It has the effects of clearing away heat and detoxifying, eliminating phlegm, and relieving sore throat. It is used for heat toxins, phlegm and fire stagnation, sore throat, excessive phlegm, cough and asthma. Modern pharmacological studies have shown that herb has a good effect on the treatment of bronchitis, chronic bronchial asthma, pulmonary interstitial fibrosis, respiratory distress syndrome, acute pharyngitis and various inflammations.

[0019] The herb Houttuynia cordata Thunb. in the prescription is the fresh whole herb or dried aerial part of Houttuynia cordata Thunb. of the Saururaceae family. It is pungent and slightly cold in nature. It enters the lung meridian. It has the effects of clearing away heat and detoxifying, eliminating carbuncle and draining pus, and promoting diuresis and relieving stranguria. It is used for lung carbuncle vomiting pus, phlegm-heat cough, heat dysentery, heat stranguria, carbuncle, sore and toxicity. Modern pharmacological studies have shown that herb Houttuynia cordata has anti-inflammatory, anti-tumor, antiviral, antibacterial, antioxidant, and immunomodulatory effects.

[0020] The honeysuckle in the prescription is the dried buds or flowers with just opened flowers of Lonicera japonica Thunb. of the Caprifoliaceae family. It tastes sweet and is cold in nature. It enters the lung, heart and stomach meridians. It has the effects of clearing away heat and detoxifying, and evacuating wind-heat. It is used for carbuncle, furuncle, throat paralysis, erysipelas, heat-toxic bloody dysentery, wind-heat cold, and fever caused by febrile diseases. Modern pharmacological studies have shown that honeysuckle has the effects of antipyretic, anti-inflammatory, antibacterial, antiviral, antioxidant, anti-ultraviolet, liver-protecting and gallbladder-promoting, and immunity-enhancing.

[0021] The Trichosanthes peel in the prescription is the dried mature peel of the Trichosanthes kirikrwii Maxim. or Trichosanthes rosthornii Harms of the Cucurbitaceae family. It tastes sweet and is cold in nature. It enters the lung and stomach meridians. It has the effects of clearing away heat and resolving phlegm, promoting qi and relieving chest tightness. It is used for cough caused by phlegm and heat, chest tightness and flank pain. Modern pharmacological studies have shown that the Trichosanthes peel has multiple pharmacological activities such as anti-atherosclerosis, protection against ischemia-reperfusion injury, and expectoration.

[0022] The earthworm in the prescription is the dried body of Pheretima aspergillum (E. Perrier), an animal of the family Lumbricidae. It tastes salty and is cold in nature. It enters the liver, spleen, and bladder meridians. It has the effects of clearing away heat and calming the nerves, unblocking the meridians, relieving asthma, and diuresis. It is used for high fever and coma, epilepsy and convulsions, joint pain, limb numbness, hemiplegia, lung heat and cough, edema and oliguria. It is an important raw material for the marketed Chinese patent medicines such as Naoxintong Capsules, Shuxuetong Injection, Zhike Pingchuan Pills, and Fufang Dilong Capsules. It has been widely used to treat diseases such as stroke, diabetes, and asthma, and can improve hypertension, hyperglycemia, and hyperlipidemia.

[0023] The salvia miltiorrhiza in the prescription is the dried root and rhizome of Salvia miltiorrhiza Bge., a plant of the Labiatae family. It tastes bitter and is slightly cold in nature. It enters the heart and liver meridians. It has the effects of promoting blood circulation and removing blood stasis, relieving pain by promoting menstruation, clearing the heart and eliminating vexation, cooling blood and eliminating carbuncle. It is used for chest pain, pain in the abdomen and flanks, accumulation of masses, pain due to heat arthralgia, restlessness and insomnia, irregular menstruation, dysmenorrhea and amenorrhea, and swelling and pain in sores. Modern pharmacological studies have shown that salvia miltiorrhiza has the effects of protecting vascular endothelial cells, improving the body's tolerance to hypoxia, anti-inflammatory, anti-lipid peroxidation, scavenging free radicals, protecting liver cells, and resisting pulmonary fibrosis.

[0024] The licorice in the prescription is the dried root and rhizome of Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat. or Glycyrrhiza glabra L. of the leguminous plants. It tastes sweet and is neutral in nature. It enters the heart, lung, spleen and stomach meridians. It has the effects of tonifying the spleen and replenishing qi, clearing away heat and detoxifying, removing phlegm and relieving cough, relieving urgency and relieving pain, and harmonizing various medicines. It is used for spleen and stomach weakness, fatigue, palpitations and shortness of breath, cough with sputum, acute pain in the abdomen and limbs, carbuncle, sore and poison, and relieves the toxicity and potency of drugs. Modern pharmacological studies have shown that licorice has biological activities such as detoxification, antibacterial and anti-tumor. Clinically, it is often used in the compatibility of traditional Chinese medicine compound prescriptions to play the role of harmonizing the middle and relieving urgency and harmonizing various medicines.

[0025] Compared with the prior art, the technical effects created by the present invention are embodied in:

[0026] The prescription of the present invention is scientific and reasonable in proportion. In the prescription, roasted ephedra is pungent, bitter and warm, can dispel lung heat, relieve asthma, and dispel pathogens; gypsum is pungent, sweet and extremely cold, can clear lung heat to produce body fluid and relieve cough, and can dispel pathogens by dispersing and dispersing muscles. The two medicines are used together, one is warm and the other is cold, and can be used together to dispel heat and dissipate qi, and are the main medicine. Bitter almonds can descend lung qi, relieve asthma and cough, and can be matched with ephedra to dissipate lung qi, relieve cough and relieve asthma; Belamcanda is bitter and cold, can dissipate qi, is good at clearing lung fire, benefiting the throat, and is good at removing phlegm, and is a common medicine for treating phlegm-blocked cough and asthma; Houttuynia cordata is pungent and dispersing, and is cold in nature and enters the lungs. It is good at clearing heat and detoxifying, eliminating carbuncle and discharging pus, and has remarkable effects in treating lung heat, cough and asthma, and phlegm. They are all ministerial medicines. Honeysuckle is sweet and cold, and can clear heat from both the qi and blood. It also has a slight dispersing effect while clearing heat, and can dissipate wind-heat and clear internal heat. Trichosanthes peel is sweet and cold, and can clear heat and phlegm, promote qi and relieve chest tightness. Earthworms are salty and cold, and can clear heat and calm convulsions, relieve asthma and promote urination. Salvia miltiorrhiza is good at promoting blood circulation and removing blood stasis. Its use in pneumonia is inspired by the important argument of "water-qi disease if blood is not smooth" in "Golden Chamber Synopsis". It is used to promote blood circulation and promote water, improve lung microcirculation, and promote the absorption of lung inflammation. All of them are adjuvants. The adjuvant drug licorice can invigorate qi and harmonize the middle, prevent the severe cold of gypsum from damaging the middle, and harmonize the other drugs. The whole prescription is compatible, and the effects of opening and closing the lungs, clearing heat and resolving phlegm are particularly prominent. DETAILED DESCRIPTION

[0027] The technical solution of the present invention is further defined below in conjunction with specific implementation methods, but the scope of protection required is not limited to the description.

[0028] Example 1

[0029] Weigh 5kg of roasted ephedra, 20kg of gypsum, 6kg of bitter almond, 6kg of belamcanda, 10kg of houttuynia, 10kg of honeysuckle, 8kg of trichosanthes peel, 6kg of earthworm, 8kg of salvia miltiorrhiza, and 6kg of liquorice. Add gypsum to water and boil for 30 minutes, then add the remaining roasted ephedra and other nine ingredients, boil twice, each for 1 hour, filter, combine the filtrate, concentrate to a suitable relative density, let stand, filter, add stevioside and sodium benzoate to the filtrate, add water to adjust the total amount, stir well, filter, fill, sterilize, and obtain. The prepared mixture or oral solution is equivalent to about 1.4g of the decoction piece per 1ml.

[0030] Example 2

[0031] Weigh 2kg of roasted ephedra, 10kg of gypsum, 5kg of bitter almond, 15kg of belamcanda, 25kg of houttuynia, 15kg of honeysuckle, 15kg of guawei peel, 15kg of earthworm, 15kg of salvia miltiorrhiza, and 2kg of liquorice. Add water to the gypsum and boil for 30 minutes, then add the remaining roasted ephedra and other nine ingredients, boil twice, each for 1 hour, filter, combine the filtrate, concentrate to a suitable relative density, let stand, add stevioside and sodium benzoate to the filtrate, add water to adjust the total amount, stir well, filter, fill, sterilize, and obtain. The prepared mixture or oral solution is equivalent to about 1.4g of the decoction piece per 1ml.

[0032] Example 3

[0033] Weigh 10kg of roasted ephedra, 60kg of gypsum, 15kg of bitter almond, 3kg of belamcanda, 3kg of houttuynia, 3kg of honeysuckle, 3kg of guawei peel, 3kg of earthworm, 3kg of salvia miltiorrhiza, and 15kg of liquorice. Add water to gypsum and boil for 30 minutes, then add the remaining roasted ephedra and other nine ingredients, boil twice, each for 1 hour, filter, combine the filtrate, concentrate to a suitable relative density, let stand, add stevioside and sodium benzoate to the filtrate, add water to adjust the total amount, stir well, filter, fill, sterilize, and obtain. The prepared mixture or oral solution is equivalent to about 1.4g of the decoction piece per 1ml.

[0034] Example 4

[0035] Weigh 5kg of roasted ephedra, 20kg of gypsum, 6kg of bitter almond, 6kg of belamcanda, 10kg of houttuynia, 10kg of honeysuckle, 8kg of trichosanthes peel, 6kg of earthworm, 8kg of salvia miltiorrhiza, 8kg of radish seeds, and 6kg of liquorice. Add water to the gypsum and boil for 30 minutes, then add the remaining ten flavors such as roasted ephedra, boil twice, each for 1 hour, filter, combine the filtrate, concentrate to a suitable relative density, let stand, add stevioside and sodium benzoate to the filtrate, add water to adjust the total amount, stir well, filter, fill, sterilize, and obtain. The prepared mixture or oral solution is equivalent to about 1.4g of the decoction piece per 1ml.

[0036] Example 5

[0037] Weigh 5kg of roasted ephedra, 20kg of gypsum, 6kg of bitter almond, 6kg of beam dry, 10kg of houttuynia, 10kg of honeysuckle, 8kg of trichosanthes peel, 6kg of earthworm, 8kg of salvia, 8kg of fritillaria, and 6kg of liquorice. Add water to the gypsum and boil for 30 minutes, then add the remaining roasted ephedra and other ten flavors, boil twice, each for 1 hour, filter, combine the filtrate, concentrate to a suitable relative density, let stand, add stevioside and sodium benzoate to the filtrate, add water to adjust to the total amount, stir well, filter, fill, sterilize, and obtain. The prepared mixture or oral solution is equivalent to about 1.4g of the decoction piece per 1ml.

[0038] Example 6

[0039] Weigh 5kg of roasted ephedra, 20kg of gypsum, 6kg of bitter almond, 6kg of belamcanda, 10kg of houttuynia, 10kg of honeysuckle, 8kg of trichosanthes peel, 6kg of earthworm, 8kg of salvia miltiorrhiza, 6kg of perilla seed, 6kg of scutellaria baicalensis, and 6kg of liquorice. Add water to the gypsum and boil for 30 minutes, then add the remaining roasted ephedra and other eleven flavors, boil twice, each for 1 hour, filter, combine the filtrate, concentrate to a suitable relative density, let stand, add stevioside and sodium benzoate to the filtrate, add water to adjust the total amount, stir well, filter, fill, sterilize, and obtain. The prepared mixture or oral solution is equivalent to about 1.4g of the decoction piece per 1ml.

[0040] Example 7

[0041] Weigh 5kg of roasted ephedra, 20kg of gypsum, 6kg of bitter almond, 6kg of belamcanda, 10kg of houttuynia, 10kg of honeysuckle, 8kg of trichosanthes peel, 6kg of earthworm, 8kg of salvia, 6kg of magnolia, and 6kg of liquorice. Add water to the gypsum and boil for 30 minutes, then add the remaining ten flavors such as roasted ephedra, boil twice, each time for 1 hour, filter, combine the filtrate, concentrate to a suitable relative density, let stand, add stevioside and sodium benzoate to the filtrate, add water to adjust the total amount, stir well, filter, fill, sterilize, and obtain. The prepared mixture or oral solution is equivalent to about 1.4g of the decoction piece per 1ml.

[0042] Example 8

[0043] Weigh the Chinese herbal medicine pieces of roasted ephedra 5g, gypsum 20g, bitter almond 6g, belamcanda 6g, houttuynia cordata 10g, honeysuckle 10g, trichosanthes peel 8g, earthworm 6g, salvia miltiorrhiza 8g, and liquorice 6g. Add water to gypsum and decoct for 30 minutes, then add other medicines and decoct for 20 minutes, filter out the first decoction; then add appropriate amount of water, decoct for 15 minutes, and filter out the second decoction. Combine the two decoctions to about 180ml.

[0044] Example 9

[0045] Weigh 2g of roasted ephedra, 10g of gypsum, 5g of bitter almond, 15g of belamcanda, 25g of houttuynia, 15g of honeysuckle, 15g of guaweipi, 15g of earthworm, 15g of salvia miltiorrhiza, and 2g of liquorice. Add water to gypsum and decoct for 30 minutes, then add other drugs and decoct for 20 minutes, filter out the first decoction; then add appropriate amount of water, decoct for 15 minutes, filter out the second decoction. Combine the two decoctions to about 180ml.

[0046] Example 10

[0047] Weigh 10g of roasted ephedra, 60g of gypsum, 15g of bitter almond, 3g of belamcanda, 3g of houttuynia cordata, 3g of honeysuckle, 3g of guaweipi, 3g of earthworm, 3g of salvia miltiorrhiza, and 15g of liquorice. Add water to gypsum and decoct for 30 minutes, then add other drugs and decoct for 20 minutes, filter out the first decoction; then add appropriate amount of water, decoct for 15 minutes, filter out the second decoction. Combine the two decoctions to about 180ml.

[0048] Embodiment 11

[0049] Weigh 5g of roasted ephedra, 20g of gypsum, 6g of bitter almond, 6g of belamcanda, 10g of houttuynia cordata, 10g of honeysuckle, 8g of trichosanthes peel, 6g of earthworm, 6g of radish seed, 8g of salvia miltiorrhiza, and 6g of liquorice. Add water to gypsum and decoct for 30 minutes, then add other drugs and decoct for 20 minutes, filter out the first decoction; then add appropriate amount of water, decoct for 15 minutes, filter out the second decoction. Combine the two decoctions to about 180ml.

[0050] Example 12

[0051] Weigh 5g of roasted ephedra, 20g of gypsum, 6g of bitter almond, 6g of belamcanda, 10g of houttuynia cordata, 10g of honeysuckle, 8g of trichosanthes peel, 6g of earthworm, 8g of salvia miltiorrhiza, 8g of fritillaria thunbergii, and 6g of liquorice. Add water to gypsum and decoct for 30 minutes, then add other drugs and decoct for 20 minutes, filter out the first decoction; then add appropriate amount of water, decoct for 15 minutes, filter out the second decoction. Combine the two decoctions to about 180ml.

[0052] Example 13

[0053] Weigh 5g of roasted ephedra, 20g of gypsum, 6g of bitter almond, 6g of belamcanda, 10g of houttuynia cordata, 10g of honeysuckle, 8g of trichosanthes peel, 6g of earthworm, 8g of salvia miltiorrhiza, 6g of perilla seed, 6g of scutellaria baicalensis seed, and 6g of liquorice. Add water to gypsum and decoct for 30 minutes, then add other drugs and decoct for 20 minutes, filter out the first decoction; then add appropriate amount of water, decoct for 15 minutes, filter out the second decoction. Combine the two decoctions to about 180ml.

[0054] Embodiment 14

[0055] Weigh 5g of roasted ephedra, 20g of gypsum, 6g of bitter almond, 6g of belamcanda, 10g of houttuynia cordata, 10g of honeysuckle, 8g of trichosanthes peel, 6g of earthworm, 8g of salvia miltiorrhiza, 6g of magnolia, and 6g of liquorice. Add water to gypsum and decoct for 30 minutes, then add other drugs and decoct for 20 minutes, filter out the first decoction; then add appropriate amount of water, decoct for 15 minutes, filter out the second decoction. Combine the two decoctions to about 180ml.

[0056] Pharmacodynamics experiment of the Chinese medicine composition of the present application

[0057] 1. Purpose of the test

[0058] According to the functional characteristics and therapeutic scope of the Chinese medicine composition mixture of the present application, the test methods and relevant observation indicators are selected to examine its anti-inflammatory, antitussive, expectorant and antipyretic effects, so as to provide pharmacodynamic experimental basis support for its clinical application.

[0059] II. Experimental Animals and Test Drugs

[0060] 1. Experimental animals

[0061] SPF 8-week-old SD rats, weighing 180-220 g, SPF 12-week-old albino guinea pigs, weighing 380-420 g, were provided by Beijing Weitonglihua Experimental Animal Technology Co., Ltd., animal license number SCXK (Beijing) 2021-0006. Actual breeding conditions: room temperature 24-26 ° C, humidity 60%, animal use license number: SYXK Gui 2022-0001.

[0062] (II) Test drugs and groups

[0063] 1. Drug under test

[0064] The Chinese medicine composition of the present application is provided by Guangxi International Zhuang Medicine Hospital (the proportion of ingredients is the same as in Example 1). Clinical Usage and Dosage: Oral, 20 ml once, 3 times a day. Specification: 100 ml per bottle (each ml contains about 1.42 g of the decoction piece).

[0065] 2. Experimental Grouping

[0066] Normal control group: distilled water. Positive control group: ibuprofen tablets 0.2 g / tablet, Xiuzhen Pharmaceutical Group Co., Ltd.; Pediatric phlegm and cough granules 5 g / bag, produced by Guiyang Shumeida Pharmaceutical Factory Co., Ltd.; enteric-coated aspirin tablets 100 mg / tablet, produced by Bayer, Germany.

[0067] (III) Experimental reagents and instruments

[0068] 1. Experimental Reagents

[0069] Interleukin-1β (IL-1β), interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), and prostaglandin 2 (PGE2) ELISA assay kits are all products of Shanghai Fanke Industrial Co., Ltd.

[0070] 2. Experimental Instruments

[0071] CODA small animal blood pressure assessment system, Kent Company, USA; S1016MR oral and nasal inhalation exposure system, a product of Shanghai Yuyan Scientific Instrument Co., Ltd.; Multiskan microplate reader, Thermo Company; BCE224i-1CCN analytical balance, Beijing Sartorius Scientific Instrument Co., Ltd.; TDL-5-A high-speed centrifuge, Shanghai Anting Scientific Instrument Factory; electronic thermometer, Shandong Shangnong Electronic Technology Co., Ltd.

[0072] 3. Experimental Methods

[0073] The Chinese medicine composition of the present application is derived from a clinical prescription, and has the effects of promoting lung function, opening and closing, and clearing away heat and resolving phlegm. It is suitable for children with pneumonia, wheezing, wind-heat blocking the lungs, phlegm-heat blocking the lungs, etc., with symptoms such as cough, expectoration, wheezing, fever, and medium and fine wet rales in the lungs. According to the functional characteristics and main treatment range of the drug, the pharmacodynamics study of its anti-inflammatory, antitussive, expectorant and antipyretic effects is carried out.

[0074] (I) Dose setting

[0075] Three dose groups were set for each test substance, and the drug dose was expressed in g / kg (amount of decoction pieces / animal body weight). According to the "Methodology of Chinese Medicine Pharmacology Research", the dose conversion is calculated based on the body surface area ratio. Based on the clinical decoction piece amount of 85g / day for children, the equivalent dose for rats (180g) and children is 28.2g / kg (equivalent dose = 85g (daily dose for children) ÷ 35kg (weight of children) × 12.33 (coefficient of 150g rats by body surface area method) × 0.941 (correction coefficient of 180g rats and 150g standard rats) = 28.2g / kg, which is approximately 12 times the daily dose for children). The equivalent dose for guinea pigs (400g) and children is 11.2g / kg (equivalent dose = 85g (daily dose for children) ÷ 35kg (weight of children) × 4.63 (coefficient of 150g rats by body surface area method) = 11.2g / kg, which is approximately 5 times the clinical daily dose for children). The dose groups are low dose, which is 1 / 2 times the equivalent dose, medium dose, which is the equivalent dose, and high dose, which is 2 times the equivalent dose. The dose of the positive control drug is equal to the equivalent dose for children calculated by body surface area ratio.

[0076] (II) Dosage method and frequency

[0077] Each test was performed by intragastric administration, and the administration volume for rats and guinea pigs was 10 ml / kg, once a day, and the administration period was 3-7 days.

[0078] 3. Statistical methods

[0079] All data are The data were expressed in the form of t-test and SPSS13.0 statistical software was used to compare the differences between groups, and variance analysis was performed for each group to compare the differences between groups.

[0080] (IV) Main steps

[0081] 1. Antipyretic effect of the Chinese medicine composition of the present application on dry yeast-induced fever model in rats

[0082] SPF grade 3-4 week old young SD rats, half male and half female, were fed adaptively for 3 days, and the rectal temperature of the rats was measured once in the morning, noon and evening every day. Before each temperature measurement, the thermometer probe was coated with vaseline and inserted into the rat rectum 2.5cm (marked with a black marker at 2.5cm of the thermometer to ensure that the insertion depth was consistent each time), and the body temperature value was recorded after the reading was stable. The measurement was continued for 3 days, and 60 healthy rats with a basal rectal temperature of 37.5-38.5℃ were selected and randomly divided into 6 groups: normal control group, model control group, ibuprofen tablet group (0.3g / kg), high, medium and low doses of the Chinese medicine composition of the present application (56.4, 28.2, 14.1g / kg) group, 10 rats in each group. Each group of rats was given the corresponding drug by gavage at 10ml / kg body weight, and the normal control group and the model control group were given the corresponding volume of distilled water, once a day, for 3 consecutive days. Before the experiment, rats were fasted but not watered for 12 h. Body temperature was measured twice in the morning of the experiment, and the average value was taken as the basal body temperature. One hour after the last administration, each group of animals was subcutaneously injected with 10 ml / kg of 20% dry yeast suspension, and the normal control group was subcutaneously injected with an equal volume of saline. Body temperature was measured once at 0.5, 2, 4, 6, 8, 9, 10, and 11 after injection, for a total of 8 times. The data were recorded and compared with the basal body temperature to calculate the temperature change value (△℃) (measured body temperature-basal body temperature).

[0083] The results are shown in Tables 1 and 2. Compared with the normal control group, the body temperature of the rats in the model control group decreased 0.5h to 2h after the injection of the dry yeast suspension, and the body temperature increased at 4h and thereafter, and continued until 11h, and the difference was statistically significant (P < 0.01), indicating that the fever model was successfully prepared. Compared with the model control group, the body temperature of the rats in the ibuprofen group and the high-, medium-, and low-dose groups of the Chinese medicine composition of the present application decreased significantly 4h after the injection of the dry yeast suspension, and the temperature decrease was maintained until 10h, and the difference was statistically significant (P < 0.05, P < 0.01). The results show that the Chinese medicine composition of the present application has an antipyretic effect on febrile young mice.

[0084] Table 1 Effect of the Chinese medicine composition of the present application on the temperature changes of young rats induced by dry yeast

[0085]

[0086] Table 2 Effect of the Chinese medicine composition of the present application on the temperature changes of young rats induced by dry yeast

[0087]

[0088] Note: Compared with the normal control group, * P < 0.05; ** P<0.01; compared with the model control group, # P<0.05,## P<0.01

[0089] 2. Effect of the Chinese medicine composition of the present application on ammonia-induced cough in guinea pigs

[0090] Fifty young guinea pigs aged 3 to 4 weeks were selected, half male and half female. After adaptive feeding for 3 days, they were randomly divided into 5 groups: a model control group, a pediatric phlegm and cough relieving granules (10.0 g / kg) group, and a high, medium, and low dose (22.4, 11.2, 5.6 g / kg) group of the Chinese medicine composition granules of the present application, with 10 in each group. The guinea pigs in the drug-treated group were given oral administration once a day, and the model control group was given an equal volume of distilled water for 7 consecutive days. One hour after the drug administration on the 7th day, the guinea pigs were placed in the oral and nasal inhalation exposure system, 25% ammonia water was added to the system, the automatic atomization and monitoring program was turned on, and the spray was performed for 30 seconds. The guinea pig cough latency, the total number of guinea pig coughs within 5 minutes and 10 minutes of atomization were observed and recorded.

[0091] The results are shown in Table 3. Compared with the model control group, the guinea pigs in the children's phlegm-relieving and cough-relieving granules group and the high, medium and low dose groups of the Chinese medicine composition of the present application had a prolonged cough latency period and a reduced number of coughs within 5 and 10 minutes, and the difference was statistically significant (P < 0.05, P < 0.01). The results show that the Chinese medicine composition of the present application has a cough-relieving effect.

[0092] Table 3 Effect of the Chinese medicine composition of the present application on ammonia-induced cough in guinea pigs

[0093]

[0094] Note: Compared with the model control group # P<0.05, ## P<0.01

[0095] 3. Effect of the Chinese medicine composition of the present application on phenol red secretion in rat trachea

[0096] Fifty SPF 3-4 week old SD rats, half male and half female, were randomly divided into 5 groups after 3 days of adaptive feeding: normal control group, pediatric phlegm and cough relieving granules (10.0 g / kg) group and high, medium and low dose (56.4, 28.2, 14.1 g / kg) groups of the Chinese medicine composition granules of the present application, with 10 rats in each group. The rats in the drug administration group were intragastrically administered once a day, and the normal control group and the model control group were given an equal volume of distilled water for 7 consecutive days. Before the experiment, the rats were fasted but not watered for 12 hours. One hour after the last intragastrically administered, 5% phenol red solution (0.1 mL / 10 g) was intraperitoneally injected. The rats were killed 0.5 hours after the injection of phenol red solution, the tissues around the trachea were stripped, and a section of the trachea from the thyroid cartilage to the tracheal branch was cut off (the same length of trachea was taken for each rat), placed in a test tube containing 3 mL of normal saline, and then 0.1 mL of sodium hydroxide test solution was added. After fully soaking for 4 hours, centrifuge at 3000 rpm / min for 15 minutes, take the supernatant, and measure the absorbance (A) value at a wavelength of 546 nm. 3 As a solvent, the absorbance (OD) of phenol red at concentrations of 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, and 3.00 ug / mL was measured, and a regression equation was calculated using the phenol red concentration and OD value. The tracheal phenol red secretion of each group of rats was calculated based on the regression equation.

[0097] The results are shown in Table 4. Compared with the normal control group, the phenol red secretion in the trachea of ​​the rats in the children's phlegm-relieving and cough-relieving granules group and the high, medium and low dose groups of the Chinese medicine composition of the present application increased, and the difference was statistically significant (P < 0.01). The results show that the Chinese medicine composition of the present application has an expectorant effect.

[0098] Table 4 Effect of the Chinese medicine composition of the present application on phenol red secretion in rat trachea

[0099]

[0100] Note: Compared with the normal control group, ## P<0.01

[0101] 4. Effect of the Chinese medicine composition of the present application on cotton ball granuloma in rats

[0102] 50 SPF grade 3-4 week old SD rats, half male and half female, were randomly divided into 5 groups after adaptive feeding for 3 days: model control group, enteric-coated aspirin tablets (0.1g / kg) group and high, medium and low dose (56.4, 28.2, 14.1g / kg) group of the Chinese medicine composition of the present application, 10 rats in each group. Before the experiment, the rats were depilated on the abdomen, anesthetized by intraperitoneal injection of sodium pentobarbital at 40mg / kg, and 2 sterilized cotton balls (20mg each) were implanted subcutaneously in the left and right groins of the rats. Rats inoculated with cotton balls were continuously gavaged for 7d, and the drug administration group was administered according to the dose of each group, and the model control group was given the corresponding volume of distilled water. After the last administration, the original incision was opened, the cotton balls were taken out together with the surrounding connective tissue, the adipose tissue was removed, and the cotton balls were placed in a 37°C oven to dry for 24h to constant weight, and the mass was weighed. The mass of cotton ball granuloma was obtained by subtracting the original mass of the cotton balls from the weighed mass. Blood was collected from the abdominal aorta of rats, and serum IL-1β, IL-6, TNF-α, and PGE 2 level.

[0103] The results are shown in Table 6. Compared with the model control group, the mass of cotton ball granuloma in rats in the aspirin enteric-coated tablet group and the high, medium and low dose groups of the Chinese medicine composition of the present application was reduced, and the difference was statistically significant (P < 0.05). The results show that the Chinese medicine composition of the present application has an anti-inflammatory effect.

[0104] The results are shown in Table 7. Compared with the model control group, the serum inflammatory factors IL-1β, IL-6, TNF-α, PGE 2 The level was reduced, and the difference was statistically significant (P < 0.05). The results showed that the Chinese medicine composition of the present application has an inhibitory effect on inflammatory factors.

[0105] Table 6 Effect of the Chinese medicine composition of the present application on cotton ball granuloma in rats

[0106]

[0107] Note: Compared with the model control group, # P<0.05

[0108] Table 7 IL-1β, IL-6, TNF-α, PGE 2 Level comparison

[0109]

[0110] Note: Compared with the model control group, # P<0.05

[0111] IV. Conclusion

[0112] The Chinese medicine composition of the present application has anti-inflammatory, antitussive, expectorant and antipyretic effects, and has a significant therapeutic effect on pneumonia and asthma in children.

[0113] Typical clinical cases

[0114] The patient, Zhang, male, 5 years old. First visit on March 22, 2018. Cough for five days, accompanied by fever for four days. Five days ago, he began to have symptoms of cough, nasal congestion, and clear runny nose. He had fever the next day, with a peak temperature of 39.7℃, no vomiting or convulsions. His parents took oral medicines such as "Chiqiao Qingre Granules for Children, Compound Zinc Cloth Granules, and Compound Licorice Mixture", but the fever did not subside, and the cough increased, so he came for diagnosis. Symptoms include fever, heavy cough, occasional coughing of yellow sticky sputum, no obvious wheezing, poor appetite, occasional vomiting, and good sleep at night. Physical examination: clear consciousness, good spirit, red pharynx, slightly coarse breathing in both lungs by auscultation, dry and wet rales can be heard in the right lung, red tongue, and thick white fur in the middle. DR chest anteroposterior and lateral films suggest "bronchial pneumonia", and the test for Mycoplasma pneumoniae antibodies is positive. The diagnosis is wind-heat blocking the lungs with wheezing and coughing caused by pneumonia, and the treatment is to open and close the lungs, resolve phlegm and stop coughing. Select the Chinese medicine decoction prepared by the embodiment of the present invention 8, one dose per day, each time 60ml, divided into three times for continuous medication for three days, and cooperate with short-term back application powder for external treatment. After three days of follow-up, fever has retreated, coughing is reduced, sputum is difficult to cough up, coughing and spitting sputum, poor appetite. After physical examination: good spirit, stable breathing, slightly red pharynx, light red tongue, thin white fur, dry and wet rales in both lungs. As can be seen, the child's surface evil has been resolved at this time, and the heat has subsided, and the panting and coughing are reduced, but the remaining phlegm is not exhausted, and the purging white Erchen Decoction is used instead to clear the remaining heat and resolve phlegm and benefit the lungs, and the follow-up is carried out after serving for one week, and all symptoms are flat, and the condition is cured.

[0115] Finally, it should be pointed out that the above embodiments are only representative examples of the present invention. Obviously, the technical solution of the present invention is not limited to the above embodiments, and there are many variations. All variations that can be directly derived or associated with the content disclosed by ordinary technicians in this field should be considered as the protection scope of the present invention.

Claims

1. A Chinese medicine composition for treating pneumonia and cough in children, characterized in that: The invention comprises the following raw materials: roasted ephedra, gypsum, bitter almond, belamcanda, houttuynia cordata, honeysuckle, melon peel, earthworm, salvia miltiorrhiza and licorice.

2. The Chinese medicine composition according to claim 1, characterized in that: The weight proportions of the raw materials are: 2-10 parts of roasted ephedra, 10-60 parts of gypsum, 5-15 parts of bitter almonds, 3-15 parts of belamcanda chinensis, 3-25 parts of houttuynia cordata, 3-15 parts of honeysuckle, 3-15 parts of cucurbitacin peel, 3-15 parts of earthworm, 3-15 parts of salvia miltiorrhiza, and 2-15 parts of liquorice.

3. The Chinese medicine composition according to claim 1, characterized in that The weight proportions of the raw materials are: 5 parts of roasted ephedra, 20 parts of gypsum, 6 parts of bitter almonds, 6 parts of belamcanda chinensis, 10 parts of houttuynia cordata, 10 parts of honeysuckle, 8 parts of trichosanthes peel, 6 parts of earthworms, 8 parts of salvia miltiorrhiza, and 6 parts of liquorice.

4. The Chinese medicine composition according to claim 1, characterized in that: It also includes one or more of radish seed, Fritillaria thunbergii, Perilla seed, Lemongrass seed, and Magnolia officinalis.

5. The Chinese medicine composition according to claim 4, characterized in that: The weight proportions of the raw materials are: 2-10 parts of roasted ephedra, 10-60 parts of gypsum, 5-15 parts of bitter almonds, 3-15 parts of belamcanda chinensis, 3-25 parts of houttuynia cordata, 3-15 parts of honeysuckle, 3-15 parts of cucurbitacin peel, 3-15 parts of earthworms, 3-15 parts of salvia miltiorrhiza, 3-15 parts of radish seeds, 3-15 parts of thunbergii bulbs, 3-15 parts of perilla seeds, 3-15 parts of scutellaria baicalensis seeds, 3-15 parts of magnolia buds, and 2-15 parts of liquorice.

6. Use of the Chinese medicine composition according to claim 1 as or in the preparation of a medicine for treating pneumonia and asthma in children.

7. A mixture or oral solution prepared using the Chinese medicine composition according to claim 1.

8. A decoction prepared using the Chinese medicine composition according to claim 1.

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