CN115282243B

CN115282243B - Traditional Chinese medicine composition for treating pediatric acute bronchitis and preparation method thereof

Info

Publication number: CN115282243B
Application number: CN202210677044.2A
Authority: CN
Inventors: 王志斌; 张书明; 张连中; 张涛; 张钊恺
Original assignee: Beijing Langzhen Pharmaceutical Technology Co ltd
Current assignee: Beijing Langzhen Pharmaceutical Technology Co ltd
Priority date: 2022-06-16
Filing date: 2022-06-16
Publication date: 2023-09-19
Anticipated expiration: 2042-06-16
Also published as: CN115282243A

Abstract

The invention relates to a traditional Chinese medicine composition for treating acute bronchitis in children and a preparation method thereof, wherein the traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials in parts by weight: 20-40g of ephedra, 100-200g of honeysuckle, 50-150g of perilla, 100-200g of radix stemonae, 100-200g of aster, 200-300g of gypsum, 300-400g of cordate houttuynia, 50-150g of semen lepidii, 100-200g of coltsfoot flower and 50-150g of bitter apricot seed.

Description

Traditional Chinese medicine composition for treating pediatric acute bronchitis and preparation method thereof

Technical field:

the invention relates to a traditional Chinese medicine composition, in particular to a traditional Chinese medicine composition for treating pediatric acute bronchitis and a preparation method thereof.

The background technology is as follows:

children cough is classified into exogenous cough and internal injury cough.

The infant has the symptoms of inadequate qi, weak skin and insecurity. Children are not aware of the self-regulation of cold and warm, are difficult to adapt to the change of external climate, and are most likely to be affected by six exogenous pathogens.

The cough caused by exogenous pathogenic factors is mainly in the lung, the lung is mainly qi, and the lung is breathed, and the upper airway is connected with the throat, and the nose is opened, and the skin and hair are combined externally, so that the cough caused by exogenous pathogenic factors is the waggon of the five zang organs. The lung is a tender organ and is directly communicated with the outside. No matter the exogenous evil is entered from the mouth and nose or from the fur, the lung must first run with it, so that the lung qi is not dispersed and is clear and descending, and the upward adverse rise of the lung qi is cough. The exterior evil stagnates the lung, qi failing to distribute body fluid and body fluids are coagulated to form phlegm. The four times of changes are different, the pathogenic factors are also different, the exogenous pathogenic factors affecting the lung wind is the leading cause, and the pathogenic factors of cold, summer heat, dryness and dampness can invade along with the wind. In spring, excessive wind attacks the person, and the lung is affected by pathogenic factors, failing to clear and descend, which is manifested as cough. Cold in winter is caused by the pathogenic cold being bound to the surface of the muscles, which can cause cough due to the obstruction of lung qi. Summer heat the children are affected by summer heat, and the children are impaired by summer heat, consume the body fluid and consume the qi, the heat evil forces the lung, the body fluid impairs the lung and dryness, and the children are unappropriated to descend, and the children are coughed by qi flow in reverse. In summer, if the infant is fumigated by damp-heat, it will get summerheat and damp evil, and block the lung channel, and cough will occur. The infant lung is tender and loving to moisten and dislike, is not heat-resistant and is not more resistant to dryness, and dryness and heat evil attack the lung, hurt the lung and burn the body fluid, and the loss of body fluid causes dry cough. Wind is the long term of all diseases, and the pathogenic wind invades the body. Cough is caused by six exogenous pathogenic factors, but cough due to wind-cold and cough due to wind-heat are the most common among exogenous cough. Wind is a yang evil, which is very likely to enter the interior to transform heat. Children are the body of young yang, and are accumulated with heat, and even if they feel wind-cold, they will have a short time to dispel heat into the interior, and similar to invasion of wind-heat exogenous evil, they all have symptoms of phlegm-heat stagnating in the lung.

Cough caused by exogenous pathogenic factors in children, which is caused by both exterior and interior heat, is often referred to as exterior-interior syndrome. For children cough due to exogenous pathogenic factors, it is indicated for cough due to exogenous pathogenic factors and internal symptoms by dispersing lung qi, resolving phlegm and relieving cough, and is indicated for cough due to exogenous pathogenic factors by clearing heat and removing phlegm. The treatment principle is as follows: relieving exterior syndrome, clearing heat, dispersing lung qi, relieving asthma, eliminating phlegm, and relieving cough.

Most of the traditional Chinese medicine cough-relieving and phlegm-resolving drugs are compound preparations, and have the function of treating both symptoms and root causes. The developed Chinese patent medicines for relieving cough and reducing sputum comprise fritillary and loquat dew, children phlegm-removing pills, children phlegm-removing oral liquid, three-fold decoction, fritillary and snow pear paste, cassia bark Long Haichuan Ning, acute-branch syrup, yin-nourishing phlegm-removing paste, snake gall and fritillary bulb liquid, mandarin duck mandarin duck fluke pills and the like, and the traditional Chinese patent medicines have curative effects, but need to be continuously developed and improved.

The Chinese herbal cough relieving oral liquid of the invention is the latest variety developed by taking previous experience and combining years of clinical practice. Has the effects of relieving exterior syndrome, clearing heat, dispersing lung qi, relieving asthma, eliminating phlegm, and relieving cough. The modern pharmacological research results show that the golden grass cough-relieving oral liquid has remarkable phlegm-relieving effect, has obvious multiple functions of antivirus, antibiosis, fever reduction and the like, and can achieve good effect of treating both symptoms and root causes.

The Chinese herbal cough-relieving oral liquid inherits the essence of the ancient prescription. More importantly, the new results of the modern medicine research are developed on the basis of the ancient prescription. The selected heat-clearing and toxicity-removing medicines have good antibacterial effect and more prominent antiviral effect. Is more targeted to the current respiratory diseases and viral infections. In the aspect of relieving cough and resolving phlegm, three medicines of stemona root, flos farfarae and aster are added besides the preserved perilla seed and pepperweed seed, so that the effect of resolving phlegm and relieving cough is obviously enhanced, and the traditional Chinese medicine composition has a certain treatment effect on acute bronchitis, persistent bronchitis and chronic bronchitis. It has the actions of relieving both exterior and interior symptoms and treating both principal and secondary aspect of disease. It can be used for treating cough due to exogenous pathogenic factor. Clinical pre-test data show that the invention is superior to acute branch syrup and children lung-heat clearing oral liquid is superior to antibiotic treatment, and is a novel medicament with unique effect for relieving cough and resolving phlegm.

The invention comprises the following steps:

the invention provides a traditional Chinese medicine composition for treating acute bronchitis in children and a preparation method thereof, wherein the traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials in parts by weight:

20-40g of ephedra, 100-200g of honeysuckle, 50-150g of perilla, 100-200g of radix stemonae, 100-200g of aster, 200-300g of gypsum, 300-400g of cordate houttuynia, 50-150g of semen lepidii, 100-200g of coltsfoot flower and 50-150g of bitter apricot seed.

Preferably, the traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials in parts by weight:

25-35g of ephedra, 140-160g of honeysuckle, 90-110g of perilla seed, 140-160g of radix stemonae, 140-160g of aster, 240-260g of gypsum, 330-350g of cordate houttuynia, 90-110g of semen lepidii, 140-160g of coltsfoot flower and 90-110g of bitter apricot seed.

Most preferably, the traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials in parts by weight:

30g of ephedra herb, 150g of honeysuckle, 100g of perilla seed, 150g of radix stemonae, 150g of aster, 250g of gypsum, 340g of cordate houttuynia, 100g of pepperweed seed, 150g of coltsfoot flower and 100g of bitter apricot seed.

The weight of the components is calculated by crude drugs, and the components can be prepared into 1000 preparations, wherein 1000 preparations refer to: the prepared finished medicine is prepared into 1000 capsules, 1000 tablets, 1000 granules and the like, and is prepared into 1000ml of oral liquid.

The components are proportioned by weight, and can be increased or reduced according to corresponding proportion during production, for example, large-scale production can be carried out in kilograms or tons, small-scale production can be carried out in milligrams, and the weight can be increased or reduced, but the proportion of the weight proportion of crude drugs among the components is unchanged.

The weight ratio is obtained by scientific screening, and for special patients, such as patients with serious or mild symptoms, obesity or small size, the ratio of the components can be correspondingly adjusted, the increase or decrease of the ratio is not more than 100%, and the efficacy is unchanged.

The single Chinese medicine in the above composition can also be replaced by proper Chinese medicine with the same medicine property, and the medicine effect of the replaced Chinese medicine preparation is unchanged.

The traditional Chinese medicine composition is prepared by extracting or otherwise processing traditional Chinese medicine raw materials consisting of the formula to prepare a pharmaceutically active substance, then taking the substance as a raw material, adding a pharmaceutically acceptable carrier when required, and preparing the traditional Chinese medicine composition according to the conventional technology of pharmaceutics. The active substances can be obtained by extracting the traditional Chinese medicine raw materials respectively, can be obtained by extracting the traditional Chinese medicine raw materials together, and can be obtained by other modes, such as: the active substances can be in the form of extract, dry extract or fluid extract, and the concentration of the active substances is determined according to different requirements of the preparation.

The weight percentage of the pharmaceutically active substances in the traditional Chinese medicine composition can be 0.1-99.9%, and the rest is pharmaceutically acceptable carrier. The traditional Chinese medicine composition disclosed by the invention exists in a unit dosage form, and the unit dosage form refers to a unit of preparation, such as each tablet of a tablet, each capsule of a capsule, each bottle of oral liquid, each bag of granules and the like.

The Chinese medicinal composition of the invention can be any pharmaceutically acceptable preparation formulation, and the formulation comprises: tablets, sugar-coated tablets, film-coated tablets, enteric-coated tablets, capsules, hard capsules, soft capsules, oral liquids, buccal agents, granules, medicinal granules, pills, powders, pastes, pellets, suspensions, powders, solutions, injections, suppositories, ointments, plasters, creams, sprays, drops and patches. The formulations of the present invention are preferably oral dosage forms, such as: capsules, tablets, oral liquid, granules, pills, powder, pills, paste and the like. Most preferred are oral liquids.

The Chinese medicinal composition of the present invention, the preparation for oral administration may contain usual excipients such as binders, fillers, diluents, tabletting agents, lubricants, disintegrants, colorants, flavoring agents and wetting agents, and if necessary, the tablets may be coated.

Suitable fillers include cellulose, mannitol, lactose and other similar fillers. Suitable disintegrants include starch, polyvinylpyrrolidone and starch derivatives, such as sodium starch glycolate. Suitable lubricants include, for example, magnesium stearate. Suitable pharmaceutically acceptable wetting agents include sodium lauryl sulfate.

The solid oral compositions may be prepared by conventional methods of mixing, filling, tabletting, and the like. Repeated mixing can distribute the active throughout those compositions using large amounts of filler.

Oral liquid preparations may be in the form of, for example, aqueous or oily suspensions, solutions, emulsions, syrups or elixirs, or may be presented as a dry product for constitution with water or other suitable vehicle before use. Such liquid preparations may contain conventional additives such as suspending agents, for example sorbitol, syrup, methylcellulose, gelatin, hydroxyethylcellulose, carboxymethylcellulose, aluminium stearate gel or hydrogenated edible fats, emulsifying agents, for example lecithin, sorbitan monooleate or acacia; non-aqueous carriers (which may include edible oils) such as almond oil, fractionated coconut oil, oily esters such as esters of glycerol, propylene glycol or ethanol; preservatives, for example methylparaben or propylparaben or sorbic acid, and may, if desired, contain conventional flavourings or colourants.

The traditional Chinese medicine composition of the invention can be selectively added with proper pharmaceutically acceptable carriers when preparing medicines, and the pharmaceutically acceptable carriers comprise but are not limited to the following materials: mannitol, sorbitol, sodium metabisulfite, sodium bisulphite, sodium thiosulfate, cysteine hydrochloride, thioglycollic acid, methionine, vitamin C, EDTA disodium, calcium sodium EDTA, monovalent alkali metal carbonates, acetates, phosphates or aqueous solutions thereof, hydrochloric acid, acetic acid, sulfuric acid, phosphoric acid, amino acids, sodium chloride, potassium chloride, sodium lactate, xylitol, maltose, glucose, fructose, dextran, glycine, starch, sucrose, lactose, mannitol, silicon derivatives, cellulose and derivatives thereof, alginates, gelatin, polyvinylpyrrolidone, glycerol, tween 80, agar, calcium carbonate, calcium bicarbonate, surfactants, polyethylene glycol, cyclodextrin, beta-cyclodextrin, phospholipid materials, kaolin, talc, calcium stearate, magnesium stearate and the like.

The dosage of the preparation is determined according to the condition of patients when the preparation is used, and the preparation can be taken three times a day, 1 to 20 doses each time, such as: 1-20 bags or granules or tablets.

Most preferably, the preparation method of the invention is as follows:

The formula comprises the following components:

30g of ephedra herb, 150g of honeysuckle, 100g of perilla seed, 150g of radix stemonae, 150g of aster, 250g of gypsum,

340g of cordate houttuynia, 100g of pepperweed seed, 150g of coltsfoot flower, 100g of bitter apricot seed,

auxiliary materials are formed by:

aspartame 3.0g

Preparing:

1000ml。

the preparation method comprises the following steps:

distilling the ten above materials with steam, and collecting 800ml of distillate; filtering the distilled water solution, and collecting the filtrate in another device; decocting the residue and the rest seven materials with water for three times, each time for l hours, mixing decoctions, filtering, mixing filtrate with the above filtrate, concentrating to obtain fluid extract with relative density of 1.20-1.25 (40deg.C), adding ethanol to make ethanol content 75%, standing overnight, filtering, and recovering ethanol from the filtrate to obtain soft extract with relative density of 1.35-1.40 (50deg.C). Adding the above water vapor distillate, boiling, cooling, refrigerating for 48 hr, filtering, and adding aspartame 3g into the filtrate. The pH was adjusted to 6.5 with a 20% sodium hydroxide solution and the total amount was adjusted to 1000ml by adding water. Stirring, bottling, and sterilizing. 10ml of each of the packages was selected.

The invention is an effective proved recipe which is summarized by combining recent research results under the guidance of traditional Chinese medicine theory and is a decoction clinical application experience of which the professor of a famous pediatric expert Fang Hesong has accumulated for over forty years.

The invention absorbs the essence of Ma xing Shi Gan decoction and Suwan, and is prepared by modification.

In the recipe, ma Huang, xin Hunjie, the drugs for dispersing lung qi and relieving asthma, gypsum Fibrosum, with pungent and cool nature, clearing lung-heat and stomach-fire, are combined together to prepare the drug for relieving exterior syndrome, dispersing lung qi, and relieving internal heat.

Honeysuckle flower, flos Lonicerae, and herba Houttuyniae, have the effect of clearing away heat and toxic materials, and are capable of clearing wind and warm heat and removing toxic substances in blood. Cough caused by exogenous pathogenic heat in children is usually caused by lung obstruction, excessive phlegm heat, cough and asthma, even mouth and nose bluish violet, cough and dyspnea, and fructus Perillae and semen Lepidii are added, lung qi is reduced, and dyspnea is relieved, and the four medicines are used as ministerial medicines together to assist monarch medicines in clearing heat and detoxicating. Regulating qi-flowing, resolving phlegm, relieving cough and asthma.

Stemona root, radix Stemonae has the effects of moistening lung, lowering adverse qi and relieving cough, and is good at treating frequent cough; ancient people considered lung-moistening and dryness-relieving, and tussilago farfara and aster are added to moisten lung, stop cough and resolve phlegm, so it is also indicated for cough due to phlegm-heat damaging fluid and warm dryness. The three medicines are used as adjuvant medicines together, and the assistant and monarch medicines are used as ministerial medicines, namely osmanthus phlegm and cough relieving effects.

Bitter apricot kernel, semen Armeniacae amarum is used as adjuvant drug to assist the effect of dispersing lung qi, relieving cough and asthma.

The cold and heat of the whole formula are combined, and the external and internal diseases are treated, so that the effects of eliminating phlegm and heat, relieving asthma and cough are achieved. It is mainly used for treating cough due to exogenous wind-heat, cold and phlegm heat, and heat due to pathogenic invasion of exogenous evil into interior, and cough and asthma due to lung heat with exterior and interior syndrome due to exterior heat and interior heat.

The traditional Chinese medicine composition has the functions of relieving cough by resolving phlegm, relieving exterior syndrome, clearing heat, freeing lung and relieving asthma. Is suitable for treating acute bronchitis of children, with symptoms of cough, yellow or white phlegm, sticky and difficult expectoration, or wheezing phlegm in throat, coarse and rapid breath, fever, thirst, pharyngalgia, dysphoria, scanty and reddish urine, dry stool, red tongue, yellow or greasy tongue fur, slippery or rapid pulse, or purple finger print.

The traditional Chinese medicine composition is preferably used for children. For facilitating children to take, the oral liquid preparation with the weight of 10ml is preferably prepared.

The beneficial effects of the invention are further illustrated by experimental data as follows:

the experiment medicine used in the following experiment of the invention, wherein the jingcao cough relieving oral liquid is prepared by the method of the embodiment 1 of the invention, and other medicines are purchased from the market.

Pharmacological toxicology

1. The Chinese medicinal herb cough-relieving oral liquid has obvious cough-relieving effect on mice cough caused by ammonia water

Taking 60 healthy mice, randomly dividing the mice into 5 groups, (1) a blank control group; (2) A small dose group of JINCAO cough relieving oral liquid (3 g crude drug/kg); (3) Dosage group (6 g crude drug/kg) of the JINCAO cough relieving oral liquid; (4) Large dose group of the Chinese herbal medicine cough relieving oral liquid (12 g crude drug/kg); (5) acute branch syrup (7.8 ml/kg); the administration route is gastric lavage administration, once daily, continuous administration for three days, half an hour after the last administration, putting the mice into a 500ml beaker, putting a cotton ball into the beaker, sucking 0.2ml ammonia water into the cotton ball by a 1ml syringe, rapidly inverting the beaker, and observing and recording the cough latency period and the cough times in 3min of the mice. The comparison between groups is performed by statistical treatment.

Conclusion: the large, medium dosage group and acute branch syrup group of the Chinese herbal cough relieving oral liquid can obviously reduce the times of cough, obviously prolong the incubation period of the cough, and has obviously poor significance (P < 0.001) compared with the control group.

2. The Chinese medicinal herb cough relieving oral liquid has obvious cough relieving effect on cough of young guinea pigs caused by citric acid

60 healthy guinea pig young mice are taken, screened in advance, respectively placed into a glass bell jar, and 17.5% citric acid is sprayed for 1 minute under the pressure of 600 mmHg. The subjects who observed less than 10 coughs in the 5 minutes after cessation of spraying were not pre-selected. Taking 50 qualified guinea pigs, randomly dividing the next day into 5 groups of 10 guinea pigs each, and (1) obtaining a blank control group; (2) A large-dose group of the golden grass cough-relieving oral liquid (8.0 g crude drug/kg; a dose group of the golden grass cough-relieving oral liquid (4.0 g crude drug/kg); (4) a small-dose group of the golden grass cough-relieving oral liquid (2.0 g crude drug/kg); (5) a quick-branch syrup group (5.4 g crude drug/kg) is administrated by gastric lavage, once daily administration, three continuous administration days, half an hour after last administration, cough-inducing experiments are carried out, the times of cough within 5 minutes are observed, and statistical treatment is carried out on the results.

Conclusion: the cough times of the large-dose group of the Chinese herbal medicine cough-relieving oral liquid are obviously reduced, and compared with the control group, the cough times of the large-dose group of the Chinese herbal medicine cough-relieving oral liquid are obviously different (P is less than 0.01); acute branch syrup also reduced cough frequency, with significant differences (P < 0.05) compared to control group.

3. The Chinese medicinal herb cough relieving oral liquid has obvious phlegm eliminating effect on mice

Healthy mice 78 were randomly divided into 6 groups of 13 mice each. (1) a blank; (2) chlorinated string group (0.5 g/kg); (3) acute branch syrup (7.8 ml/kg); (4) A small dose group of JINCAO cough relieving oral liquid (3 g crude drug/kg); (5) Dosage group (6 g crude drug/kg) of the JINCAO cough relieving oral liquid; (6) A large-dose group of JINCAO cough relieving oral liquid (12 g crude drug/kg). The administration is performed by lavage once daily for three days. The diet was fasted for 12 hours before the experiment, and no water was forbidden. Mice were sacrificed by intraperitoneal injection of 0.5ml of 0.25% phenol red solution half an hour after the last administration, fixed in the upper position, shearing off the skin in the neck, separating the trachea, inserting a flattened 7-gauge needle into the trachea about 0.3cm under the larynx, ligating with silk thread, sucking 0.4ml of 5g/dl NaHCO3 solution with a 1ml syringe, flushing the respiratory tract back and forth 3 times through the needle, repeating 4 times as above, combining 1.6ml washes 4 times into a cuvette, and measuring OD value with a spectrophotometer. Phenol red was used as a standard curve, and the phenol red content (ug/ml) was calculated from the standard curve and statistically processed.

The respiratory tract phenol red discharge amount in the Jincao cough relieving oral liquid, a large dosage group and two positive medicine groups is obviously increased compared with the control group, and the Jincao cough relieving oral liquid has obvious difference (P <0.05, P <0.01 and P < 0.001) and has no obvious difference compared with the acute branch syrup group.

4. The Chinese gooseberry cough relieving oral liquid has obvious phlegm eliminating effect on young rats

50 healthy young rats are randomly divided into 5 groups, and 10 (1) blank control groups are selected from each group; (2) Large dose group of the Chinese herbal medicine cough relieving oral liquid (8.0 g crude drug/kg); (3) Dosage group (4.0 g crude drug/kg) of the JINCAO cough relieving oral liquid; (4) A small dose group of the Chinese herbal medicine cough relieving oral liquid (2.0 g crude drug/kg); (5) acute branch syrup group (5.4 ml/kg). The diet was fasted for 12 hours before the experiment, and no water was forbidden. After anesthesia with 1% pentobarbital sodium, fixing in the upward position, cutting open skin in neck, separating trachea, inserting glass capillary tube with length of 5cm and diameter of 1.5mm in the middle of formative cartilage, taking liquid column length in capillary tube as evaluation effect of eliminating phlegm, recording normal secretion amount 1h before administration, and administering by intragastric administration after lh. Sputum secretion was measured 1h, 2h after dosing. The dosing group was compared to the control group and statistically treated.

There was no significant difference between the pre-dose and the 1h, 2h sputum after dose in the control group. The respiratory sputum of each dosage group and acute branch syrup group of the jingcao cough relieving oral liquid is obviously increased, and compared with the oral liquid before administration, the oral liquid has obvious differences (P <0.05, P <0.01, P < 0.001) and the oral liquid has obvious differences (P <0.05, P <0.01, P < 0.001) compared with the oral liquid in the control group.

5. The Chinese medicinal herb cough-relieving oral liquid has obvious asthma-relieving effect on bronchial asthma

70 healthy guinea pig young mice are taken, screened in advance, respectively placed into a glass bell jar, and mixed liquid of equal amount of 2% of acetylcholine chloride and 0.1% of histamine phosphate is sprayed for 15 seconds under the pressure of 400 mmHg. The guinea pig's wheezing latency (i.e. the time from onset of spraying to onset of asthma, dyspnea, until twitch fall) was observed after cessation of spraying and was not selected for >120 seconds. Taking 60 qualified guinea pigs, randomly dividing the next day into 6 groups of 10 guinea pigs each, and (1) obtaining a blank control group; (2) A small dose group of the Chinese herbal medicine cough relieving oral liquid (2 g crude drug/kg); (3) Dosage group (4 g crude drug/kg) of the JINCAO cough relieving oral liquid; (4) Large dose group of the Chinese herbal medicine cough relieving oral liquid (8 g crude drug/kg); (5) acute branch syrup (5.4 ml/kg); (6) Aminophylline groups (0.lg/kg) were administered by gavage once daily for three consecutive days and half an hour after the last administration, the asthma-relieving experiment was performed. Experimental observations were made for 6 minutes (360 seconds), and the asthma latency of the non-falling person was calculated in 360 seconds. The results were statistically processed.

Aminophylline can obviously inhibit asthma reaction, prolong latency, and has obvious difference compared with a control group; the large, medium dose group and the positive group of the Chinese herbal medicine cough relieving oral liquid also have the functions of prolonging the incubation period of asthma, the occurrence of convulsion and the occurrence of the prolonged falling time, and have obvious differences (P <0.05, P <0.01 and P < 0.001) compared with the control group. The large dosage group of the Chinese medicinal herb cough relieving oral liquid has better effect than the acute branch syrup group (P < 0.05) in prolonging the time of convulsion and falling.

6. The Chinese medicinal oral liquid can inhibit viral replication in mice, and relieve lung lesions

1) Mouse lung index and lung index inhibition rate assay and virus content assay in lung: the number of healthy Kunming mice is 70, and the mice are randomly divided into 7 groups, namely, normal control (water supply), virus control (water supply), acute branch syrup (7.8 ml/kg), shuanghuanglian oral liquid (5 ml/kg), and large (12 g crude drug/kg), medium (6 g crude drug/kg) and small (3 g crude drug/kg) dosage groups, and 10 groups are respectively male and female half. Animals in each group were given a total of 7 days by gavage or water, respectively, starting from two days before infection to day 5 after infection. The mice of each group were treated with 15LD under mild anesthesia, except for the normal group ₅₀ Is infected by 50ul of virus, and 50ul of normal control group is dripped with physiological saline in the same way. 24 hours after the last 1 dose, the mice are weighed, eyeballs are picked up for bleeding and killing, the whole lung is taken out for weighing through aseptic operation, the lung index and the lung index inhibition ratio are calculated, and the virus content in the lung is measured.

The method for measuring the virus content in the lung of the mouse comprises the following steps: grinding whole lung in glass grinder, preparing into 10% suspension with sterile physiological saline, and preparing into sterile NSDilutions of different concentrations. Inoculating 0.2ml of each dilution into allantoic cavity of chick embryo by conventional method, incubating 5 chick embryos at 33deg.C for 72 hr, measuring hemagglutination activity of chick embryo allantoic fluid by conventional hemagglutination method, and calculating EID ₅₀ 。

2) The death protection and life extension test of virus infected mice comprises randomly dividing healthy mice into 6 groups, namely normal control, virus control, acute branch syrup, shuanghuanglian and test drug large and small dose groups. The administration method is the same as that of test 1 except for the normal control groupThe mice of the outer groups are respectively treated with 2LD ₅₀ After the viral nasal drop infection, animals were observed daily for morbidity and the number of deaths recorded for 14 days, and the mortality protection rate and life extension rate were calculated.

Conclusion 1) of the experiment: the lung of virus infected mice is swollen, and the lung index (2.02+ -0.29) is significantly greater than that of the normal group (0.88+ -0.10) (P < 0.001). The large dose of the Chinese medicinal herb cough relieving oral liquid obviously reduces the lung index (1.56+/-0.39), the difference is very obvious (P < o.oi) compared with a model group, the lung index inhibition rate reaches 22.6%, and the medium and small doses have no obvious inhibition effect.

Conclusion 2) of the experiment: EID of virus control group ₅₀ Is 10 ^-5.625 The large dose group is 10 ^-4.165 The large dose group is 28.8 times larger than the virus control group, so that 50% of chick embryos can be infected, and the jingcao cough relieving oral liquid can inhibit the replication of viruses in mice and lighten lung lesions.

Conclusion 3) of the experiment: all mice infected by the viruses die, and the mortality rate, the average survival time and the prolonged life rate of the large-dose group of the Chinese herbal cough-relieving oral liquid are obviously different from those of the virus control group (P < 0.01).

7. The Chinese medicinal herb cough relieving oral liquid has a certain inhibition effect on respiratory bacteria

The pathogenic strains and internationally recognized quality control strains clinically isolated for this test included Streptococcus pneumoniae 3, staphylococcus aureus (ATCC 25923) 10, staphylococcus epidermidis 8, pseudomonas catarrhalis 3, pseudomonas aeruginosa (ATCC 27853) 3, pseudomonas pneumoniae 7, escherichia coli 10, proteus vulgaris 3, shigella 4, staphylococcus aureus, pseudomonas aeruginosa and Escherichia coli (ATCC 25922) 1 each, 54 total strains, each of which were provided by the national academy of medical and biological technology research.

Diluting extract diluent of herba Euphorbiae Humifusae cough relieving oral liquid with concentration of 1g/ml with M-H culture medium to obtain medicinal liquid with concentration of 100, 25, 6.25 and 1.56mg/ml (crude drug), sequentially adding the medicinal liquid with each concentration into 1 ml/tube of the discharged sterile small test tube, 55 rows, and finally 1 row as medicinal liquid control without bacteria.

Gentamicin: diluted to 100pg/ml of drug solution,and diluting the mixture into 10,2.Spg/ml solution by using MH liquid culture medium, and sub-packaging the solution into 55 tubes. Fresh bacterial cultures at 1:100 or 1:1000 dilutions were added to each row of diluted drug-containing tubes at 0.1 ml/tube, and each strain control tube without drug addition was set. All test tubes are placed in a 37 ℃ incubator for culture After hours the results were observed. The approximate concentration of the minimum dilution without bacterial growth is the Minimum Inhibitory Concentration (MIC).

The experimental conclusion shows that: the MIC of the Chinese herbal medicine cough relieving oral liquid on streptococcus pneumoniae is 1.56mg/ml (crude drug). The MIC of 9 strains was 100mg/ml (crude drug), namely, 1 strain of Staphylococcus aureus and quality control strain thereof, 3 strains of Staphylococcus epidermidis, 1 strain of Katacoccus, 1 strain of Pseudomonas aeruginosa, 1 strain of Proteus and 1 strain of Klebsiella pneumoniae. The MIC of other strains is greater than 100 mg/ml. The medicine has a certain inhibition effect on respiratory bacteria.

8. The Chinese medicinal herb cough relieving oral liquid has obvious inhibition effect on mice infected with pneumococcus

The test randomly divided 60 mice into five groups, (1) control group: (2) group of acute branch syrups (7.8 ml/kg); (3) a small dosage group (3 g/kg) of the golden grass cough-relieving oral liquid; (4) dosage group (6 g/kg) of the golden grass cough-relieving oral liquid; (5) large dosage group (12 g/kg) of the golden grass cough relieving oral liquid. Mice were given once daily by gavage for seven days prior to infection. Mice were intraperitoneally injected with pneumococci at 90-100% lethal dose on day eight, mice died 72 hours post infection were observed, experimental data were obtained via X ² The effect of the drug was evaluated by inspection.

The test results show that: animals in the control group died 10 within 48 hours of being infected; the acute branch syrup group died 7; the large-dose group of the golden grass cough-relieving oral liquid dies 3; the middle and small doses die by 6 and 7 respectively. The large dose group was significantly different (P < 0.05) from the control group. The Chinese herbal cough relieving oral liquid has obvious inhibition effect on mice infected with pneumococcus.

9. The Chinese medicinal oral liquid can significantly reduce the increase of rat body temperature caused by yeast

Experimental animals were randomly divided into 6 groups of 10 animals: (1) Control group, equivalent steamed stuffing water, acute branch syrup (5.4 ml/kg); (4) The group of the Chinese herbal medicine cough-relieving oral liquid (2 g crude drug/Kg), (5) the group of the Chinese herbal medicine cough-relieving oral liquid (4 g crude drug/Kg), and (6) the group of the Chinese herbal medicine cough-relieving oral liquid (8 g/Kg).

The anal temperature of the rats was measured three times a day before the test, and the animals were subjected to subcutaneous injection of yeast suspension (15%, 10 ml/Kg) at the back of the test, and the rats with rectal temperatures less than 0.8℃were removed. The administration group simultaneously irrigates the stomach to administer the tested liquid medicine, the blank control group and the model group administer equivalent amount of steamed filling water, the body temperature of the rat is measured for 2, 3, 4, 6, 8 and 10 hours after the administration, the total body temperature is measured for 10 hours, the change of the body temperature at each time point is calculated, and the self and inter-group comparison is carried out. The test results show that: the body temperature rise amplitude of the Jincao cough relieving oral liquid after large-dose medicine combination for 3 hours is obviously lower than that of a model group (P)<0.05 Most significant 6h body temperature drop, lasting up to 10h, P compared to model group<0.001; after the medium dose is combinedThe body temperature drop was significantly lower than in model group (P<0.05、P<0.01 A) is provided; the body temperature is obviously reduced at 6h.10h after the small dose group medicine (P)<0.05). A syrup for treating acute bronchitis>The body temperature drop was significantly lower than in model group (P <0.01). The results show that the Chinese herbal cough relieving oral liquid has obvious antipyretic effect on infectious fever of the rat yeast.

10. The Chinese medicinal herb cough relieving oral liquid has obvious inhibiting effect on tissue inflammation

1) Taking 55 healthy rats, randomly dividing the healthy rats into 5 groups, (1) a blank control group; (2) group of acute branch syrups (5.4 ml/kg); (3) A small dose group of the Chinese herbal medicine cough relieving oral liquid (2 g crude drug/kg); (4) Dosage group (4 g crude drug/kg) of the JINCAO cough relieving oral liquid; (5) Large dose group of the Chinese herbal medicine cough relieving oral liquid (8 g crude drug/kg).

The administration route is that of gastric lavage, once daily administration, three days after continuous administration, 10% egg white solution is subcutaneously injected into the right foot plantar part of a rat to cause inflammation by 0.05ml, the volume change below the foot plantar joint of the rat is measured, and the average swelling rate and inhibition rate of each group 30 minutes, 1, 2, 4 and 6 hours after the inflammation are calculated and compared with each other by using T test.

The test conclusion shows that: the large, medium and small dosage groups of the golden grass cough relieving oral liquid and the acute branch syrup have obvious effect of inhibiting the swelling of the foot and plantar parts of rats at different time points within 30 minutes, 1, 2, 4 and 6 hours after the inflammation, and have obvious difference compared with a control group, and the golden grass cough relieving oral liquid group and the acute branch syrup have no obvious difference. The Chinese herbal cough relieving oral liquid has obvious inhibiting effect on tissue inflammation.

2) Healthy mice were taken 55, randomly divided into 5 groups of 11. (1) a blank; (2) acute branch syrup (7.8 ml/kg); (3) A small dose group of JINCAO cough relieving oral liquid (3 g crude drug/kg); (4) Dosage group (6 g crude drug/kg) of the JINCAO cough relieving oral liquid; (5) A large-dose group of JINCAO cough relieving oral liquid (12 g crude drug/kg). The administration is performed by stomach irrigation once a day for three days. About 0.1ml of xylene was dropped on the left ear of the mice 30 minutes after the administration on the third day, the animals were sacrificed 15 minutes later, the same parts of the left and right auricles were perforated with a 6mm punch, the two side ears were weighed respectively, the swelling degree was obtained by subtracting the weight of the right ear from the weight of the left ear of each mouse, and the swelling rates of the control group and the administration group were compared.

The test conclusion shows that: the large-dose and medium-dose groups and the acute branch syrup groups of the Chinese herbal cough relieving oral liquid have obvious inhibiting effect on the ear inflammation of mice caused by the dimethylbenzene. The left ear swelling of the mice in the administration group was significantly reduced, compared with the control group, the small dose group was also reduced, but not statistically significant, by the difference (p <0.01, p <0.05, p < 0.01) respectively. The comparison of the Jincao cough relieving oral liquid group and the positive group shows no significant difference. The Chinese herbal cough relieving oral liquid has better anti-inflammatory effect on acute superficial tissue inflammation.

11. The herba Salvia officinalis cough relieving oral liquid has effect in enhancing cellular immunity

Healthy mice were randomly divided into 7 groups of 10 mice each. (1) a blank; (2) model group (1% dnfb); (3) levamisole group (25 mg/kg); (4) Acute branch syrup (7.8 ml/kg) (5) small dose group of herba jin Cao cough relieving oral liquid (3.0 g crude drug/kg); (6) Dosage group (6.0 g crude drug/kg) of the JINCAO cough relieving oral liquid; (7) A large-dose group of JINCAO cough relieving oral liquid (12 g crude drug/kg).

The administration route is gastric administration, every administration is carried out once, the abdomen of the mice is dehaired after 2 days of administration, 1% DNFB solution is uniformly smeared on dehaired parts for sensitization, and after five days, 1% DNFB solution is uniformly smeared on the right ears (two sides) of the mice for attack, and the control group is smeared on the ears equally but not sensitized. After 24 hours, the mice were sacrificed, the left and right ears were cut off, the ears were removed with a punch, and weighed. The difference between the groups was observed using the difference in weight of the left and right ears as the swelling degree. The results were compared for significance of differences between groups by t-test.

The test conclusion shows that: the delayed allergic reaction caused by DNFB has obvious difference (P < 0.01) compared with the control group, and the large dosage group, the acute branch syrup group and the levamisole group of the jingcao cough-relieving oral liquid have obvious difference (P <0.05 and P < 0.01) compared with the model group. The Chinese gooseberry cough relieving oral liquid is administrated for seven days, so that delayed allergic reaction caused by DNFB is obviously improved, the cellular immunity level is improved, and the cellular immunity function is enhanced.

12. Acute toxicity test according to the relevant regulations of the research of new traditional Chinese medicines, the oral liquid for relieving cough of herba Salvia officinalis is subjected to the acute toxicity test of mice, and LD can not be detected ₅₀ Therefore, the maximum tolerance was measured. Mice were given by gavage with a cumulative dose of 280g crude drug/kg, equivalent to 215.4 times the clinical dose, and the animals were observed continuously for 7 days after administration without adverse reactions and death.

13. Long-term toxicity test

In order to ensure the safety of clinical medication, 80 rats of wistar species are divided into a control group and a group of crude drug/kg dosage of Chinese herbal medicine cough-relieving oral liquid (respectively 12.5 times, 25 times and 50 times of the dosage of human) according to the relevant regulations of new Chinese herbal medicine research in the Ministry of health, and the effects of Chinese herbal medicine cough-relieving oral liquid on various indexes of animals are observed by continuous gastric lavage and administration for three months. The results prove that the medicine has no obvious influence on ten biochemical indexes such as rat weight, ingestion, hemogram, heart, liver and kidney functions, electrocardiogram and the like, and the general and microscopic examination of all organs has no obvious toxic pathological change.

The invention further carries out clinical experiments:

test purpose: the effectiveness and safety of the Chinese herbal medicine cough-relieving oral liquid for treating the phlegm-heat obstructing lung of the pediatric acute bronchitis are further observed through phase II and phase III clinical tests, and the dosage of clinical use is recommended;

Design principle: layering interval, randomized, positive drug control, double-blind, multi-center clinical trial;

control drug selection: acute branch syrup produced by Fuling pharmaceutical factories of Taiji group, approval document: chinese medicine standard Z50020615;

a population of subjects; meets the western medicine diagnosis standard (pediatric acute bronchitis) of the pediatric acute bronchitis phlegm-heat obstructing lung;

sample size: phase II clinical trials 240. 120 cases of test group and control group, 60 cases in each center.

Phase III clinical trials 480. The test group was 360 cases, the control group was 120 cases, 96 cases in each center.

Treatment protocol:

test article: oral liquid of jincao for relieving cough

5ml each time for 1-3 years old is 3 times daily;

10ml each time for 3+ to 7 years old, 3 times daily;

15ml each time for the year of age, 3 times daily.

The treatment course is 5 days.

Control: the syrup is orally taken.

5ml each time for the year of age 3 times daily;

10ml each time after year of age, 3 times per Fl:

15ml each time for the year of age, 3 times daily.

The treatment course is 5 days.

The curative effect index is as follows: the main indexes are as follows:

main symptoms are as follows: (1) cough; (2) sputum amount; (3) pulmonary sign

Secondary index:

secondary symptoms: (1) fever, shortness of breath, dysphoria, sore throat, thirst, dry stool, yellow urine and other secondary symptoms;

(2) tongue proper, tongue coating, pulse condition or fingerprint; (3) total number of blood white cells and classification; (4) x-ray chest radiography or chest radiography;

(5) Nasopharyngeal virus isolation or pharyngeal swab bacterial culture.

Efficacy and safety assessment criteria:

a. disease treatment efficacy criteria:

(1) clinical recovery: the main observation indexes (cough, expectoration and lung signs) disappear, the body temperature is recovered to be normal, and the blood white cell count is recovered to be normal.

(2) The effect is shown: the main observation index is disappeared or obviously improved, the integral sum of the main observation index is reduced by more than 60 percent, the body temperature is recovered to be normal, and the blood white cell count is recovered to be normal or obviously improved.

(3) The method is effective: improvement of main observation index, integral sum of main observation index, reductionThe body temperature returns to normal or obviously decreases, and the blood white cell count is improved.

(4) Invalidation: the main observation index and the body temperature have no obvious change or aggravation, the integral sum of the main observation index is reduced by less than 30 percent, and the blood white cell count is not obviously improved.

Note that: (1) reduction rate = [ (total integral before treatment and total integral after treatment)/total integral before treatment and 1X100%;

(2) total integral = syndrome integral + lung sign integral.

b. Standard of curative effect for Chinese medicine syndrome

(1) And (3) healing: the integral sum of symptoms and abnormal tongue pulse is reduced by more than 95 percent.

(2) The effect is shown: the integral sum of symptoms and abnormal tongue pulse is reduced by more than 60 percent

(3) The method is effective: the integral sum of symptoms and abnormal tongue pulse is reduced by more than 30 percent

(4) Invalidation: the symptoms and abnormal tongue pulse are reduced by 30% or less.

The clinical trial study in the second stage proves that the golden grass cough-relieving oral liquid has a treatment effect on the phlegm-heat obstructing lung of the pediatric acute bronchitis, and the adverse reaction of the medicine is not found in the test in the II stage. Wherein:

disease efficacy comparison:

full analysis set: the cure rate of the control group is 10.34%, the total effective rate is 68.96%, the cure rate of the test group is 17.65%, and the total effective rate is 78.65%.

The following scheme set: the cure rate of the control group is 11 percent, the total effective rate is 72.48 percent, the cure rate of the test group is 17.95 percent, and the total effective rate is 79.49 percent.

Traditional Chinese medicine syndrome curative effect comparison:

full analysis set: the cure rate of the control group is 13.79%, the total effective rate is 67.24%, the cure rate of the test group is 24.17%, and the total effective rate is 80.47%;

the following scheme set: the cure rate of the control group is 14.68%, the total effective rate is 70.64%, the cure rate of the test group is 20.51%, and the total effective rate is 77.77%.

The four centers of the test are commonly connected with 240 groups of patients, all patients enter ITT and PP analysis population, and the differences among groups of baseline characteristics (demographics, etiology, medical history, disease course, attack time, illness state, combined diseases, physical examination, traditional Chinese medicine syndrome and the like) are not significant and have comparability except for thirsty ITT analysis. Curative effect analysis: for evaluating disease curative effect and traditional Chinese medicine syndrome curative effect, CMH X layered by center is adopted ² Statistical method, results show that, in addition to PP analysis of syndrome curative effect, disease curative effect, syndrome curative effect are among groupsThe ITT and PP analysis results of the curative effect and the total effective rate show that the two groups have statistical significance, and the test group is obviously higher than the control group. For the non-inferior efficacy test of the total effective rate of the disease curative effect and the syndrome curative effect, the non-inferior efficacy test is established, and the conclusion of ITT analysis and PP analysis is consistent.

Conclusion that the Chinese goldthread cough relieving oral liquid has the treatment effect on the pediatric acute bronchitis phlegm heat suffocating lung syndrome.

Clinical trial researches in three stages prove that the golden grass cough relieving oral liquid has a treatment effect on the phlegm-heat obstructing lung of the pediatric acute bronchitis, and the curative effect is not inferior to that of acute bronchitis syrup. No adverse reaction is found in the test, and the safety is good. Wherein: disease efficacy comparison:

the curative effect of the disease accords with the cure rate of the Chinese herbal medicine cough-relieving oral liquid group of a scheme set (PP set) of 23.15 percent, the obvious efficiency of 48.15 percent, the progress rate of 22.22 percent and the inefficiency rate of 6.48 percent; the recovery rate of the acute bronchitis syrup group is 19.63%, the obvious efficiency is 52.45%, the progress rate is 17.79%, and the inefficiency is 10.12%.

The recovery rate of the Chinese herbal medicine cough relieving oral liquid group of the disease curative effect and intention analysis set (ITT set) is 22.12 percent, the obvious efficiency is 46.90 percent, the progress rate is 22.12 percent, and the inefficiency is 8.85 percent; the cure rate of the acute bronchitis syrup group is 18.99%, the obvious efficiency is 50.74%, the progress rate is 17.51%, and the inefficiency is 12.76%.

Traditional Chinese medicine syndrome curative effect comparison:

the syndrome curative effect accords with the PP set of the scheme set: the recovery rate of the Chinese herbal medicine cough relieving oral liquid is 14.8%, the obvious efficiency is 64.81%, the progress rate is 14.81%, and the inefficiency is 5.56%; the cure rate of the acute bronchitis syrup group is 16.87%, the obvious efficiency is 58.28%, the progress rate is 17.48%, and the inefficiency is 7.36%.

Syndrome curative effect intention analysis set ITT set: the recovery rate of the Chinese herbal medicine cough relieving oral liquid is 14.16%, the obvious efficiency is 61.95%, the progress rate is 15.04%, and the inefficiency is 8.85%; the cure rate of the acute bronchitis syrup group is 16.32%, the obvious efficiency is 56.38%, the progress rate is 17.80%, and the inefficiency is 9.50%.

459 patients in the test co-administration group, 343 patients in the test co-administration group, 116 patients in the control silk administration group: 16 cases were removed and 9 cases were removed. According to the statistical analysis plan, 434 patients entered the PP analysis population, and 450 patients took at least one dose and had at least one visit record of effectiveness entered the ITT analysis population. Case sources, clinic 430 cases, ward 20 cases. All cases signed informed consent. All patients who entered the ITT analysis population had baseline characteristics including demographics, disease course, medical history, illness, concomitant diseases, pre-treatment concomitant medication, vital signs, physical examination, traditional Chinese medical symptoms, nasopharyngeal virus detection conditions, etc., and all differences except gender were of no significance and comparable.

The evaluation of the curative effect of the disease adopts a central layering and disease layering CMH statistical method, and results show that the difference of the two groups of curative effects has no statistical significance, and the analysis results of PP and ITT are consistent; the curative effects of the two groups of diseases are not inferior in effect comparison, and the difference has significance, namely the curative effect of the test group is not lower than that of the control group, and the analysis results of PP and ITT are consistent. The evaluation results of the primary and secondary curative effect indexes are the main symptom score sum, syndrome score sum and change condition before and after the treatment, the comparison difference between the groups has no significance statistical significance, and the PP and ITT analysis results are consistent; the evaluation of the curative effect of the syndrome is carried out by adopting a central layering CMH statistical method, and the result shows that the difference of the two groups of curative effects has no statistical significance, and the analysis results of PP and ITT are consistent; the single item of each traditional Chinese medicine syndrome is scored, the difference between the two groups of differences between the base lines after 3 days and 5 days of treatment is compared, the difference has no significance except for the dysphoria score of 3 days after treatment, and the difference has no statistical significance in the peripheral blood white cell count and the comparison between the groups before and after treatment of chest X-ray.

Clinical medication which is qualified by the clinical quality standard draft of the product is taken for 458 cases in the second and third phase clinical trial researches, and adverse events caused by the product are not found. The quality standard can meet the requirement of the medicinal safety of the product.

The clinical medicine which is qualified by the clinical quality standard draft of the product is used for completing 117 cases of effective case study in the second-stage clinical trial study, and the disease curative effect data are as follows: the recovery rate of the Jincao cough relieving oral liquid group according with the scheme set (PP set) is 17.95 percent, the obvious efficiency is 61.54 percent, the progress rate is 17.95 percent, and the inefficiency is 2.56 percent; in the three-phase clinical trial study, 326 effective cases are studied, and the disease curative effect data are: the recovery rate of the Chinese medicinal herb cough relieving oral liquid is 23.15%, the obvious efficiency is 48.15%, the progress rate is 22.22%, and the inefficiency is 6.48%.

The specific embodiment is as follows:

the invention is further illustrated by the following examples, which are not intended to be limiting.

Example 1

The formula comprises the following components:

30g of ephedra herb, 150g of honeysuckle, 100g of perilla seed, 150g of radix stemonae, 150g of aster, 250g of gypsum, 340g of cordate houttuynia, 100g of pepperweed seed, 150g of coltsfoot flower, 100g of bitter apricot seed,

auxiliary materials are formed by:

aspartame 3.0g

Preparing:

1000ml。

the preparation method comprises the following steps:

distilling the above ten materials with steam, and collecting 800ml of distillate; filtering the distilled water solution, and collecting the filtrate in another device; decocting the residue and other seven materials such as herba Ephedrae with water for three times (each for 1 hr), mixing decoctions, filtering, mixing filtrate with the above filtrate, concentrating to obtain fluid extract with relative density of 1.20-1.25 (4 0 deg.C), adding ethanol to make ethanol content 75%, standing overnight, filtering, and recovering ethanol from the filtrate to obtain soft extract with relative density of 1.35-1.40 (50deg.C). Adding the above water vapor distillate, boiling, cooling, refrigerating for 48 hr, filtering, and adding aspartame 3g into the filtrate. Adjusting pH to 6.5 with 20% sodium hydroxide solution, adding water to adjust total volume to 1000ml, stirring, packaging, and sterilizing. 10ml of each of the packages was selected.

Example 2

The formula comprises the following components:

the preparation method comprises the following steps:

distilling the above ten materials with steam, and collecting 800ml of distillate; filtering the distilled water solution, and collecting the filtrate in another device; decocting the residue and other seven materials such as herba Ephedrae with water for three times (each for l hr), mixing decoctions, filtering, mixing filtrate with the above filtrate, concentrating to obtain fluid extract with relative density of 1.20-1.25 (40deg.C), adding ethanol to ethanol content of 75%, standing overnight, filtering, and recovering ethanol from the filtrate to obtain soft extract with relative density of 1.35-1.40 (50deg.C). Adding the above water vapor distillate, boiling, cooling, refrigerating for 48 hr, filtering, concentrating and drying the filtrate, pulverizing, adding sucrose and dextrin, and making into granule 1000g.

Example 3

The formulation of the tablet comprises:

40g of ephedra herb, 200g of honeysuckle, 150g of perilla seed, 200g of radix stemonae, 200g of aster, 300g of gypsum, 400g of cordate houttuynia, 150g of pepperweed seed, 200g of coltsfoot flower and 150g of bitter apricot seed. The preparation method is the same as in example 1.

Example 4

The formula of the capsule comprises the following steps:

20g of ephedra herb, 100g of honeysuckle, 50g of perilla seed, 100g of radix stemonae, 100g of aster, 200g of gypsum, 300g of cordate houttuynia, 50g of pepperweed seed, 100g of coltsfoot flower and 50g of bitter apricot seed. The preparation method is the same as in example 1.

Example 5

The formula of the pill comprises the following components:

35g of ephedra herb, 160g of honeysuckle, 110g of perilla seed, 160g of radix stemonae, 160g of aster, 260g of gypsum, 350g of cordate houttuynia, 110g of pepperweed seed, 160g of coltsfoot flower and 110g of bitter apricot seed. The preparation method is the same as in example 1.

Example 6

The formula of the dripping pill comprises the following components:

25g of ephedra herb, 140g of honeysuckle, 90g of perilla seed, 140g of radix stemonae, 140g of aster, 240g of gypsum, 330g of cordate houttuynia, 90g of pepperweed seed, 140g of coltsfoot flower and 90g of bitter apricot seed. The preparation method is the same as in example 1.

Claims

1. An oral preparation for treating acute bronchitis in children is prepared from the following traditional Chinese medicine raw materials by weight: 20-40g of ephedra, 100-200g of honeysuckle, 50-150g of perilla, 100-200g of radix stemonae, 100-200g of aster, 200-300g of gypsum, 300-400g of cordate houttuynia, 50-150g of semen lepidii, 100-200g of coltsfoot flower and 50-150g of bitter apricot seed.

2. The oral preparation according to claim 1, which is prepared from the following traditional Chinese medicine raw materials by weight:

3. The oral preparation according to claim 1, which is prepared from the following traditional Chinese medicine raw materials by weight:

4. An oral formulation according to any one of claims 1 to 3, the dosage form being selected from: tablets, capsules, oral liquids, granules and pills.

5. The composition of claim 4, wherein the formulation is an oral liquid.

6. The Chinese medicinal composition of claim 1, wherein a suitable pharmaceutically acceptable carrier is added in the preparation of the medicament.

7. The method for preparing the Chinese medicinal composition according to claim 1, wherein the Chinese medicinal materials in the formulation are extracted or otherwise processed to prepare pharmaceutically active substances, and then the substances are used as raw materials, and pharmaceutically acceptable carriers are added when needed, so as to prepare the Chinese medicinal composition according to the conventional technology of pharmaceutics.

8. The preparation method according to claim 7, wherein the active substances are obtained by extracting the raw materials of the traditional Chinese medicine separately, or by extracting the raw materials of the traditional Chinese medicine together, or by other means: the active substances are obtained by crushing, squeezing, calcining, grinding, sieving, percolating, extracting, water extracting, alcohol extracting, ester extracting, ketone extracting and chromatography, and the active substances are in the form of extractum, and are prepared into different concentrations according to different requirements of the preparation.

9. The preparation method according to claim 7, wherein the formula is: 30g of ephedra herb, 150g of honeysuckle, 100g of perilla seed, 150g of radix stemonae, 150g of aster, 250g of gypsum, 340g of cordate houttuynia, 100g of pepperweed seed, 150g of coltsfoot flower, 100g of bitter apricot seed and 3.0g of aspartame as auxiliary materials, wherein 1000ml of the auxiliary materials are prepared;

the preparation method comprises the following steps: distilling the ten above materials with steam, and collecting 800ml of distillate; filtering the distilled water solution, and collecting the filtrate in another device; decocting the residue and the rest seven materials with water for three times, each time for 1 hour, mixing decoctions, filtering, mixing filtrate with the above filtrate, concentrating to relative density, measuring at 40deg.C to obtain fluid extract with alcohol content of 1.20-1.25, standing overnight, filtering, recovering ethanol from filtrate to relative density, measuring at 50deg.C to obtain soft extract with alcohol content of 1.35-1.40, adding the above steam distillate, boiling, cooling, refrigerating for 48 hours, filtering, adding aspartame 3g into the filtrate, regulating pH to 6.5 with 20% sodium hydroxide solution, adding water to adjust total amount to 1000ml, stirring, bottling, and sterilizing to obtain 10ml of each.