CN110742939B

CN110742939B - Preparation of traditional Chinese medicine compound composition and application thereof in treating upper respiratory tract infection

Info

Publication number: CN110742939B
Application number: CN201911069713.2A
Authority: CN
Inventors: 谭余庆; 刘丽; 梁烽焱; 张�浩; 黄灿林; 潘洁丽
Original assignee: Yili Pharmaceutical Co ltd
Current assignee: Yili Pharmaceutical Co ltd; Yili Pharmaceutical Luoding Co ltd
Priority date: 2019-11-04
Filing date: 2019-11-04
Publication date: 2021-09-07
Anticipated expiration: 2039-11-04
Also published as: CN110742939A

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a preparation method of a traditional Chinese medicine compound composition and application of the traditional Chinese medicine compound composition in treating upper respiratory tract infection. The traditional Chinese medicine compound composition comprises the following components in parts by weight: 20-40 parts of volatile oil inclusion compound, 200-300 parts of traditional Chinese medicine extract, 0.5-6 parts of sweetening agent, 3-10 parts of magnesium stearate, 2-10 parts of essence and 1000 parts of sucrose powder. The invention selects eight traditional Chinese medicines of scutellaria baicalensis, forsythia suspensa, elsholtzia, pogostemon cablin, honeysuckle stem, wild chrysanthemum, sweet wormwood herb and thin evodia leaf as medicinal materials for preparing the traditional Chinese medicine compound composition, different traditional Chinese medicines are subjected to different extraction methods to obtain solid powder, and the solid powder, the sweetener, magnesium stearate, essence and the like are subjected to dry pressing and granulation to obtain the traditional Chinese medicine compound composition. The medicine prepared from the traditional Chinese medicine compound composition provided by the invention can effectively treat common viruses in upper respiratory tract infection, and has the beneficial effects of resisting viruses, relieving fever, easing pain, resisting inflammation and the like.

Description

Preparation of traditional Chinese medicine compound composition and application thereof in treating upper respiratory tract infection

Technical Field

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a preparation method of a traditional Chinese medicine compound composition and application of the traditional Chinese medicine compound composition in treating upper respiratory tract infection.

Background

Upper respiratory tract infections are inflammations of the upper respiratory tract caused by viral infections. Clinically, it is manifested as fever, aversion to cold, nasal obstruction, nasal discharge, sneezing, headache, and pharyngalgia. Belongs to the category of 'cold' in traditional Chinese medicine. Common cold is a common clinical disease, which occurs all the year round, especially in winter and spring, and especially in alternate seasons and sudden climate change, the incidence rate is higher. The patients with cold only show symptoms of nasal obstruction, watery nasal discharge, sneezing and the like in light patients, symptoms of high fever, headache, body pain and the like in heavy patients, and even more serious patients can cause deficiency of vital qi after cold, and diseases such as acute bronchitis, pneumonia, nasosinusitis, neuritis and the like are caused secondarily, so that the life is threatened, the work and life of the patients are seriously influenced, and the pain is brought to the patients.

At present, no specific treatment method for upper respiratory tract infection caused by virus is available in Western medicine, and symptomatic or supportive treatment is mainly adopted, and antiviral drugs such as ribavirin and the like are commonly used in Western medicine for symptomatic treatment. The antiviral drug is easy to generate drug resistance after being taken for a long time, and particularly for people with special physique, such as children, pregnant women and old people, the antiviral drug is easy to induce various adverse symptoms such as gastrointestinal discomfort, nausea, vomiting and the like when being used for treating cold. At this time, the upper respiratory tract infection is safer to treat by selecting the traditional Chinese medicine, and the traditional Chinese medicine can treat both symptoms and root causes. Although various Chinese patent medicines for treating upper respiratory tract infection exist in the prior art, compared with western medicines, the Chinese patent medicines are few in types and limited in selection, and have the defects of long treatment period, poor antiviral, antipyretic, analgesic and anti-inflammatory effects and the like. In addition, in the upper respiratory tract infection, most patients have complications such as fever and inflammation, and at the moment, in order to relieve symptoms such as fever and inflammation through taking medicines, various western medicines need to be taken to solve the problem, and the western medicines can damage the liver and the kidney of the human body to a certain extent. Therefore, there is an urgent need to develop a Chinese medicinal composition that can clinically act on upper respiratory symptoms.

Disclosure of Invention

In order to overcome the problems in the prior art, the invention provides a traditional Chinese medicine compound composition which can effectively relieve upper respiratory tract infection symptoms such as cold and the like and has good antiviral, antipyretic, analgesic and anti-inflammatory effects and a preparation method thereof, so as to solve the defects in the prior art.

In order to realize the purpose of the invention, the invention provides a traditional Chinese medicine compound composition which comprises the following components in parts by weight: the volatile oil clathrate compound comprises, by weight, 20-40 parts of a volatile oil clathrate compound, 200-300 parts of traditional Chinese medicine extracts, 0.5-6 parts of a sweetening agent, 3-10 parts of magnesium stearate, 2-10 parts of essence and 1000 parts of sucrose powder, wherein the volatile oil clathrate compound is obtained by clathrating oily extracts of herba elsholtziae and pogostemon cablin by a cyclodextrin colloid milling method, and the traditional Chinese medicine extracts are water-decocted extracts of scutellaria baicalensis, fructus forsythiae, honeysuckle stems, wild chrysanthemum flowers, sweet wormwood herbs and bitter trigeminal herbs.

Further, the traditional Chinese medicine compound composition comprises the following components in parts by weight: 30-35 parts of volatile oil inclusion compound, 250-300 parts of traditional Chinese medicine extract, 1.2-2 parts of sweetening agent, 5-7 parts of magnesium stearate, 4-5 parts of essence and 1000 parts of sucrose powder.

Preferably, the traditional Chinese medicine compound composition comprises the following components in parts by weight: 34 parts of volatile oil inclusion compound, 266 parts of traditional Chinese medicine extract, 2 parts of sweetener, 5 parts of magnesium stearate, 4 parts of essence and 689 parts of sucrose powder.

Further, the volatile oil inclusion compound comprises volatile oil and cyclodextrin, the weight ratio of the volatile oil to the cyclodextrin is 1: 10-20, and the raw materials of the volatile oil comprise, by weight, 400-650 parts of elsholtzia and 400-600 parts of pogostemon cablin.

Preferably, the weight ratio of the volatile oil to the cyclodextrin is 1: 16.

Preferably, the Chinese mosla herb is 450-550 parts by weight, and the patchouli is 450-550 parts by weight.

Preferably, the Chinese mosla herb is 500 parts by weight, and the patchouli is 500 parts by weight.

Further, the cyclodextrin is beta-cyclodextrin.

Further, the traditional Chinese medicine extract comprises the following raw materials in parts by weight: 350-600 parts of scutellaria baicalensis, 400-600 parts of fructus forsythiae, 700-900 parts of honeysuckle stem, 400-650 parts of wild chrysanthemum flower, 300-600 parts of sweet wormwood and 400-600 parts of thin evodia.

Further, the traditional Chinese medicine extract comprises the following raw materials in parts by weight: 450-500 parts of scutellaria baicalensis, 450-550 parts of fructus forsythiae, 750-850 parts of honeysuckle stem, 500-550 parts of wild chrysanthemum flower, 450-520 parts of sweet wormwood herb and 450-550 parts of trifoliate bitter herb.

Preferably, the traditional Chinese medicine extract comprises the following raw materials in parts by weight: 500 parts of scutellaria baicalensis, 500 parts of fructus forsythiae, 833.3 parts of honeysuckle stem, 500 parts of wild chrysanthemum flower, 500 parts of sweet wormwood and 500 parts of thin evodia.

Furthermore, the mesh number of the sucrose powder is 80-120 meshes.

The invention also provides a preparation method of the traditional Chinese medicine compound composition, which comprises the following steps: taking the sweetening agent, the magnesium stearate, the volatile oil inclusion compound, the traditional Chinese medicine extract, the essence and the sucrose powder according to the formula ratio, mixing uniformly, and performing dry pressing and granulation to obtain the compound.

Further, the preparation method of the volatile oil inclusion compound comprises the following steps: s1, adding water, and extracting herba Moslae and herba Agastaches by steam distillation to obtain volatile oil; s2, including the volatile oil obtained in the step S1 with cyclodextrin, drying and crushing to obtain a volatile oil inclusion compound;

further, the preparation method of the traditional Chinese medicine extract comprises the following steps: s3, decocting fructus forsythiae, honeysuckle stem, wild chrysanthemum flower, sweet wormwood herb, thin evodia leaf and radix scutellariae with water to obtain decoction, filtering the decoction, and concentrating the decoction to obtain extract with the relative density of 1.10-1.14 at 50 ℃; s4, adding ethanol into the extract obtained in the step S3, standing, filtering, concentrating to form thick paste with the relative density of 1.25-1.30 at 50 ℃, drying, and crushing to obtain the traditional Chinese medicine extract.

Preferably, in step S1, the weight of water is 6 times of the weight of the elsholtzia and pogostemon cablin.

Further, in step S1, the extraction time is 3-5 h.

Preferably, in step S1, the extraction time is 4 h.

Further, in step S3, the number of times of water decoction is 2, the first time of decoction is added with 6-10 times (by weight) of water, and the decoction is carried out for 1-3 hours, the second time of decoction is added with 5-8 times (by weight) of water, and the decoction is carried out for 1-3 hours, and the decoctions are combined to obtain a decoction, and the decoction is filtered and concentrated to an extract with a relative density of 1.10-1.14 at 50 ℃; in step S3, the charging sequence of the traditional Chinese medicines is as follows: decocting fructus forsythiae, honeysuckle stem, wild chrysanthemum flower, sweet wormwood herb and thin evodia leaf in water until the temperature of a water extracting solution reaches 85-95 ℃, and then adding scutellaria baicalensis.

Preferably, in step S3, the number of times of water decoction is 2, 8 times of water is added for the first time of decoction and 1.5 hours of decoction, 6 times of water is added for the second time of decoction and 1.5 hours of decoction, the decoctions are combined to obtain a decoction, the decoction is filtered and concentrated to an extract with a relative density of 1.10-1.14 at 50 ℃; in step S3, the charging sequence of the traditional Chinese medicines is as follows: decocting fructus forsythiae, caulis Lonicerae, flos Chrysanthemi Indici, herba Artemisiae Annuae, and thin Evodia in water, adding Scutellariae radix when the water extractive solution reaches 90 deg.C.

Further, in step S4, the volume ratio of the ethanol to the extract is 6-10: 3.

Preferably, in step S4, ethanol is added to the extract in step S3, and the volume ratio of the ethanol to the extract is 7: and 3, standing for 2 hours, filtering, concentrating to obtain thick paste with the relative density of 1.25-1.30 at 50 ℃, vacuum-drying at 75 ℃, and crushing.

The invention also provides application of the traditional Chinese medicine compound composition in a medicine for treating upper respiratory tract infection.

Further, the preparation form of the medicine is liquid preparation, tablet, capsule, granule, pill, powder or paste.

Scutellaria baicalensis: the product is prepared from plants of Scutellaria of Labiatae; bitter and cold; it enters lung, gallbladder, spleen, stomach, large intestine and small intestine meridians; has effects in clearing away heat, eliminating dampness, purging pathogenic fire, removing toxic substances, stopping bleeding, and preventing miscarriage; it can be used for treating chest distress, emesis, dysentery, jaundice, cough due to lung heat, hyperpyrexia, polydipsia, hematemesis, carbuncle, swelling, sore, and threatened abortion.

Fructus forsythiae: the product is fruit of Forsythia suspensa (Thunb.) Vahl) belonging to the family Oleaceae; bitter and slightly cold; it enters lung, heart and gallbladder meridians; has the effects of clearing away heat and toxic materials, eliminating carbuncle and resolving hard mass, and can be used for treating affection of exogenous wind-heat, fever due to epidemic febrile disease, pyocutaneous disease, swelling and pain, and lymphoid tuberculosis.

Herba Moslae: the product is prepared from plants of Elsholtzia of Labiatae; pungent taste and slightly warm nature; entering lung and stomach meridians; has effects of inducing sweat, relieving exterior syndrome, eliminating dampness, regulating the middle warmer, inducing diuresis, and relieving edema, and can be used for treating summer-heat and dampness exterior syndrome, edema and dysuresia.

Patchouli: the product is Labiatae plant, perennial upright plant of herbaceous plant; pungent and mild-warm; spleen, stomach and lung meridians entered; has the effects of eliminating turbid pathogen with aromatics, regulating the middle warmer, relieving vomit, relieving exterior syndrome, and relieving summer-heat; it can be used for treating damp obstruction in middle warmer, abdominal distention, emesis, summer-heat dampness syndrome, early stage of damp-warm syndrome, fever, listlessness, chest distress, cold-dampness, summer-heat, abdominal pain, emesis, diarrhea, nasosinusitis, headache, etc.

Honeysuckle stem: the product is a plant belonging to Caprifoliaceae of Rubiales; sweet and cold; entering heart and lung meridians; has effects of clearing away heat and toxic materials, and dredging collaterals; it is mainly used for treating fever due to epidemic febrile disease, dysentery with bloody stool due to heat toxin, infectious hepatitis, carbuncle, swelling, sore, and arthralgia and myalgia.

Wild chrysanthemum flower: the product is perennial herb of Compositae; bitter, pungent and slightly cold; entering liver and heart meridians; has effects of clearing away heat and toxic materials, purging pathogenic fire, and calming liver; it can be used for treating furuncle, carbuncle, swelling, conjunctival congestion, swelling and pain, headache, and vertigo.

Sweet wormwood herb: the product is dried aerial part of Artemisia annua L of Compositae; bitter, pungent and cold; it enters liver and gallbladder meridians; has effects in clearing away summer-heat, removing steam, and preventing malaria; can be used for treating fever due to summer-heat, fever due to yin deficiency, night fever with early coolness, malaria with cold and heat, damp-heat jaundice, etc.

Bitter taste in trigeminal: the product is Rutaceae plant; bitter taste and cold nature; the Chinese medicinal composition has effects of clearing away heat and toxic materials, dispelling pathogenic wind, and removing dampness; can be used for treating swelling and pain of throat, rheumatalgia, malaria, jaundice, eczema, dermatitis, traumatic injury, insect bite, snake bite, etc.

The applicant discovers that main chemical components in the sweet wormwood comprise flavonoids, coumarins, terpenoids, phenylpropanoids, various volatile oils, coumarins scopoletin and the like through component analysis of eight traditional Chinese medicines, wherein most of the chemical components in the sweet wormwood extract are fat-soluble, and the applicant discovers that the effect of water-soluble components in the sweet wormwood extract on upper respiratory infection symptoms is more remarkable than that of the fat-soluble components in the test process. The eight traditional Chinese medicines are classified, and volatile oil extracted from the elsholtzia and the patchouli is included by cyclodextrin, so that effective ingredients acting on upper respiratory tract infection in the elsholtzia and the patchouli can be better reserved.

Therefore, compared with the prior art, the traditional Chinese medicine compound composition has the following beneficial effects:

(1) the traditional Chinese medicine compound composition has good inhibition effect on H1N1 influenza virus (FM1/PR8 strain) and respiratory syncytial virus, can obviously reduce the virus expression level, and has good effect when being applied to the preparation of the medicine for treating upper respiratory infection.

(2) Compared with western medicines, the traditional Chinese medicine compound composition also has good antipyretic, analgesic and anti-inflammatory effects. Compared with western medicines, the antipyretic, analgesic and anti-inflammatory effects can be realized by patients without taking various medicines, and the safety of medication is greatly improved.

Detailed Description

The present invention is further illustrated by the following description of specific embodiments, which are not intended to limit the invention, and various modifications and improvements can be made by those skilled in the art based on the basic idea of the invention, but within the scope of the invention, without departing from the basic idea of the invention.

Example 1

The traditional Chinese medicine compound composition of the embodiment 1 is prepared from the following components in parts by weight: 20 parts of volatile oil inclusion compound, 300 parts of traditional Chinese medicine extract, 0.5 part of sucralose, 3 parts of magnesium stearate, 10 parts of apple essence and 666.5 parts of sucrose powder.

The traditional Chinese medicine extract is prepared from the following raw materials in parts by weight: 350 parts of scutellaria baicalensis, 600 parts of fructus forsythiae, 700 parts of honeysuckle stem, 400 parts of wild chrysanthemum flower, 600 parts of sweet wormwood and 600 parts of thin evodia.

The volatile oil is prepared from the following raw materials in parts by weight: 400 parts of Chinese mosla herb and 600 parts of cablin potchouli herb; the weight ratio of the volatile oil to the beta-cyclodextrin in the volatile oil inclusion compound is 1: 10.

The preparation method of the volatile oil clathrate compound comprises the following steps:

s1, adding herba Moslae, herba Agastaches, and water 5 times of the total weight of herba Moslae and herba Agastaches, and extracting by steam distillation for 3 hr to obtain volatile oil;

s2, clathrating the volatile oil obtained in the step S1 by a beta-cyclodextrin colloid mill, drying and crushing to obtain the volatile oil clathrate compound.

The preparation method of the traditional Chinese medicine extract comprises the following steps:

s3, adding water 10 times of the total weight of fructus forsythiae, caulis Lonicerae, flos Chrysanthemi Indici, herba Artemisiae Annuae, thin Evodia and radix Scutellariae, decocting, adding fructus forsythiae, caulis Lonicerae, flos Chrysanthemi Indici, herba Artemisiae Annuae and thin Evodia, adding radix Scutellariae after the water extractive solution of fructus forsythiae, caulis Lonicerae, flos Chrysanthemi Indici, herba Artemisiae Annuae and thin Evodia reaches 85 deg.C, decocting for 3h, filtering, and pouring out the first decoction; adding 8 times of water into the residual dregs, continuously decocting for 3 hours to obtain a second decoction, mixing the decoctions, filtering the decoction, and concentrating to obtain an extract with the relative density of 1.10-1.14 at 50 ℃;

s4, adding ethanol into the extract obtained in the step S3, wherein the volume ratio of the ethanol to the extract is 6:3, standing for 2 hours, filtering, concentrating to obtain thick paste with the relative density of 1.25-1.30 at 50 ℃, drying at 75 ℃, and crushing to obtain a traditional Chinese medicine extract;

the preparation method of the traditional Chinese medicine compound composition of the embodiment 1 comprises the following steps: taking sucralose, magnesium stearate, the volatile oil inclusion compound, the traditional Chinese medicine extract, essence and sucrose powder in the formula amount in the traditional Chinese medicine compound composition in the embodiment 1, mixing uniformly, and performing dry pressing and granulation to obtain the compound preparation.

Example 2

The traditional Chinese medicine compound composition of the embodiment 2 is prepared from the following components in parts by weight: 40 parts of volatile oil inclusion compound, 200 parts of traditional Chinese medicine extract, 6 parts of aspartame, 10 parts of magnesium stearate, 2 parts of banana essence and 742 parts of sucrose powder.

The traditional Chinese medicine extract is prepared from the following raw materials in parts by weight: 600 parts of scutellaria baicalensis, 400 parts of fructus forsythiae, 900 parts of honeysuckle stem, 650 parts of wild chrysanthemum flower, 300 parts of sweet wormwood and 400 parts of thin evodia.

The volatile oil is prepared from the following raw materials in parts by weight: 650 parts of Chinese mosla herb and 400 parts of cablin potchouli herb; the weight ratio of the volatile oil to the beta-cyclodextrin in the volatile oil inclusion compound is 1: 20.

s1, adding herba Moslae, herba Agastaches, and water 8 times of the total weight of herba Moslae and herba Agastaches, and extracting by steam distillation for 5 hr to obtain volatile oil;

s3, adding 6 times of water of fructus forsythiae, caulis Lonicerae, flos Chrysanthemi Indici, herba Artemisiae Annuae, thin Evodia and radix Scutellariae, decocting, adding fructus forsythiae, caulis Lonicerae, flos Chrysanthemi Indici, herba Artemisiae Annuae and thin Evodia, adding radix Scutellariae after the water extractive solution of fructus forsythiae, caulis Lonicerae, flos Chrysanthemi Indici, herba Artemisiae Annuae and thin Evodia reaches 95 deg.C, decocting for 1h, and pouring out the first decoction; adding 5 times of water into the residual dregs, decocting for 1 hour to obtain a second decoction, mixing the decoctions, filtering the decoction, and concentrating to obtain an extract with the relative density of 1.10-1.14 at 50 ℃;

s4, adding ethanol into the extract obtained in the step S3, wherein the volume ratio of the ethanol to the extract is 10:3, standing for 2 hours, filtering, concentrating to obtain thick paste with the relative density of 1.25-1.30 at 50 ℃, drying at 75 ℃, and crushing to obtain a traditional Chinese medicine extract;

the preparation method of the traditional Chinese medicine compound composition of the embodiment 2 comprises the following steps: taking aspartame, magnesium stearate, the volatile oil inclusion compound, the traditional Chinese medicine extract, banana essence and sucrose powder in the formula amount in the traditional Chinese medicine compound composition in the embodiment 2, uniformly mixing, and performing dry pressing and granulation to obtain the compound preparation.

Example 3

The traditional Chinese medicine compound composition of the embodiment 3 is prepared from the following components in parts by weight: 34 parts of volatile oil inclusion compound, 266 parts of traditional Chinese medicine extract, 2 parts of sucralose, 5 parts of magnesium stearate, 4 parts of green apple essence and 689 parts of sucrose powder.

The traditional Chinese medicine extract is prepared from the following raw materials in parts by weight: 500 parts of scutellaria baicalensis, 500 parts of fructus forsythiae, 833.3 parts of honeysuckle stem, 500 parts of wild chrysanthemum flower, 500 parts of sweet wormwood and 500 parts of thin evodia.

The volatile oil is prepared from the following raw materials in parts by weight: 500 parts of Chinese mosla herb and 500 parts of cablin potchouli herb; the weight ratio of the volatile oil to the beta-cyclodextrin in the volatile oil inclusion compound is 1: 16.

s1, adding herba Moslae, herba Agastaches, and 6 times of water, extracting with steam distillation for 4 hr to obtain volatile oil;

s2, clathrating the volatile oil obtained in the step S1 by a beta-cyclodextrin colloid mill method, drying and crushing to obtain a volatile oil clathrate compound, wherein the weight ratio of the volatile oil to the beta-cyclodextrin is 1: 16;

s3, adding 8 times of water of fructus forsythiae, caulis Lonicerae, flos Chrysanthemi Indici, herba Artemisiae Annuae, thin Evodia and radix Scutellariae, decocting, adding fructus forsythiae, caulis Lonicerae, flos Chrysanthemi Indici, herba Artemisiae Annuae and thin Evodia, adding radix Scutellariae after the water extractive solution of fructus forsythiae, caulis Lonicerae, flos Chrysanthemi Indici, herba Artemisiae Annuae and thin Evodia reaches 90 deg.C, decocting for 1.5h, and pouring out the first decoction; continuously adding 6 times of water into the residual dregs, decocting for 1.5h to obtain a second decoction, mixing the decoctions, filtering the decoction, and concentrating to obtain an extract with the relative density of 1.10-1.14 at 50 ℃;

s4, adding ethanol into the extract obtained in the step S3, wherein the volume ratio of the ethanol to the extract is 7:3, standing for 2 hours, filtering, concentrating to obtain thick paste with the relative density of 1.25-1.30 at 50 ℃, drying at 75 ℃, and crushing to obtain a traditional Chinese medicine extract;

the preparation method of the traditional Chinese medicine compound composition of embodiment 3 comprises the following steps: taking sucralose, magnesium stearate, the volatile oil inclusion compound, the traditional Chinese medicine extract, the green apple essence and sucrose powder in the formula amount in the traditional Chinese medicine compound composition in the embodiment 3, uniformly mixing, and performing dry pressing and granulation to obtain the compound preparation.

Example 4

The traditional Chinese medicine compound composition of the embodiment 4 is prepared from the following components in parts by weight: 25 parts of volatile oil inclusion compound, 250 parts of traditional Chinese medicine extract, 1.2 parts of sucralose, 7 parts of magnesium stearate, 5 parts of strawberry essence and 711.8 parts of sucrose powder.

The traditional Chinese medicine extract is prepared from the following raw materials in parts by weight: 500 parts of scutellaria baicalensis, 450 parts of fructus forsythiae, 800 parts of honeysuckle stem, 500 parts of wild chrysanthemum flower, 520 parts of sweet wormwood herb and 500 parts of thin evodia.

The volatile oil is prepared from the following raw materials in parts by weight: 450 parts of Chinese mosla herb and 550 parts of cablin potchouli herb; the weight ratio of the volatile oil to the beta-cyclodextrin in the volatile oil inclusion compound is 1: 16.

s1, adding herba Moslae, herba Agastaches, and water 7 times of the total weight of herba Moslae and herba Agastaches, and extracting by steam distillation for 3.5 hr to obtain volatile oil;

s2, clathrating the volatile oil obtained in the step S1 by a beta-cyclodextrin colloid mill method, drying and crushing to obtain a volatile oil clathrate compound, wherein the weight ratio of the volatile oil to the beta-cyclodextrin is 1: 14;

s3, adding water 7 times of the total weight of fructus forsythiae, caulis Lonicerae, flos Chrysanthemi Indici, herba Artemisiae Annuae, thin Evodia and radix Scutellariae, decocting, adding fructus forsythiae, caulis Lonicerae, flos Chrysanthemi Indici, herba Artemisiae Annuae and thin Evodia, adding radix Scutellariae after the extractive solution of fructus forsythiae, caulis Lonicerae, flos Chrysanthemi Indici, herba Artemisiae Annuae and thin Evodia reaches 90 deg.C, decocting for 2h, and pouring out the first decoction; continuously adding 6 times of water into the residual dregs, decocting for 1.5h to obtain a second decoction, mixing the decoctions, filtering the decoction, and concentrating to obtain an extract with the relative density of 1.10-1.14 at 50 ℃;

s4, adding ethanol into the extract obtained in the step S3, wherein the volume ratio of the ethanol to the extract is 8:3, standing for 2 hours, filtering, concentrating to obtain thick paste with the relative density of 1.25-1.30 at 50 ℃, drying at 75 ℃, and crushing to obtain a traditional Chinese medicine extract;

the preparation method of the traditional Chinese medicine compound composition of embodiment 4 comprises the following steps: taking sucralose, magnesium stearate, the volatile oil inclusion compound, the traditional Chinese medicine extract, the strawberry essence and sucrose powder in the formula amount in the traditional Chinese medicine compound composition in the embodiment 4, uniformly mixing, and performing dry pressing and granulation to obtain the compound preparation.

Comparative example 1

Comparative example 1 is a positive drug ribavirin granule (ribavirin granule: Sichuan Baili pharmaceutical industry, Limited liability company, national drug Standard: H51023508), administered at 82.5mg/kg body weight.

Comparative example 2

Comparative example 2 is an oral liquid for rapidly clearing away heat from children (syrup for rapidly clearing away heat from children: Heilongjiang treasure island pharmaceutical Co., Ltd., national standard of medicine: Z20153067), and the dosage is 16.5 mL.

Comparative example 3

Comparative example 3 was aspirin (aspirin effervescent tablet (pamil): a product of aspirin pharmaceutical co., ltd., lot No. 1708164, production date 2017.08, expiration date to 2019.07), and the amount administered was 0.18g/kg body weight.

Comparative example 4

Comparative example 4 was diclofenac sodium (diclofenac sodium enteric-coated tablet: product of Beijing Nowa pharmaceutical Co., Ltd., product batch No. X1150, production date 2017.08, expiration date to 2022.07), and the dose was 0.008g/kg body weight.

Comparative example 5

The ingredients in the herbal compound composition of comparative example 5 and the preparation method thereof were the same as in example 3, except that the methods of herbal extracts were different. The preparation method of the traditional Chinese medicine extract of comparative example 5 is as follows:

s3 extracting herba Artemisiae Annuae with 65% ethanol for 1.5 hr to obtain herba Artemisiae Annuae ethanol extract;

s4, adding 8 times of water of fructus forsythiae, caulis Lonicerae, flos Chrysanthemi Indici, thin Evodia and Scutellariae radix, decocting, adding Scutellariae radix after the extractive solution of fructus forsythiae, caulis Lonicerae, flos Chrysanthemi Indici and thin Evodia reaches 90 deg.C, decocting for 1.5h, and pouring out the first decoction; continuously adding 6 times of water into the residual dregs, decocting for 1.5h to obtain a second decoction, mixing the decoctions, filtering the decoction, and concentrating to obtain an extract with the relative density of 1.10-1.14 at 50 ℃;

s5, adding ethanol into the extract obtained in the step S3, wherein the volume ratio of the ethanol to the extract is 7:3, standing for 2 hours, filtering to obtain a filtrate, adding the arteannuol extract obtained in the step S2 into the filtrate, concentrating to obtain a thick paste with the relative density of 1.25-1.30 at 50 ℃, drying at 75 ℃, and crushing to obtain the traditional Chinese medicine extract.

Test example 1 influence of the Chinese herbal compound composition of the present invention on pulmonary index and pulmonary index inhibition rate of mice infected with FMI strain

The effectiveness of the samples of examples 1 to 4 and comparative examples 1 to 2 was evaluated by using a mouse pneumonia model caused by infection with H1N1 influenza virus (FM1/PR8 strain) and using the pulmonary index and the inhibition rate thereof as indices.

90 ICR mice (license number: SCXK (Jing) 2016-. Each group had 10. Wherein, the comparative example 1 is a positive drug ribavirin granule, the clinical dosage of human is 450mg/60kg/d, and the equivalent dosage converted into mouse is 82.5 mg/kg; the dose of examples 1 to 4 and comparative example 5 was 22g crude drug/kg; comparative example 2 is an oral liquid for rapidly clearing heat from children, and the dosage is 16.5 mL. Except for the normal control group, the mice were lightly anesthetized with ether, infected with 15 LD50 influenza virus solutions (FMI strain) by nasal drip, each 35. mu.l, administered on the day of infection, and gavage was performed with 0.2ml/10g of body weight each time, 1 time per day for 4 consecutive days, and the normal control group and the model control group were gavaged with distilled water under the same conditions. Weighing on day 5, dissecting the mice, taking lungs, weighing the lungs, calculating the lung index and lung index inhibition rate, and leaving the specimen for determining the viral load in lung tissues. The lung index and the lung index inhibition rate are respectively shown in formulas (I) and (II), and the test results are shown in Table 1: (I) lung index ═ lung wet weight (g) × 100 per body weight (g).

(II)

。

TABLE 1 therapeutic Effect on ICR mouse pneumonia model infected with H1N1 influenza virus strain FM1

Note: compared with the normal control group,^##P<0.01; p compared to model control group<0.05，**P<0.01

As can be seen from table 1, after the influenza a virus H1N1 strain FM1 virus is used to infect mice, the pulmonary index of the mice is obviously increased, and the pulmonary index is significantly different from that of a normal control group (P < 0.01); after the traditional Chinese medicine compound composition provided by the invention and used for treating the infection on the day of infection, the lung index is obviously reduced after the traditional Chinese medicine compound composition provided by the embodiments 1-4 is administered for 4 days, and the lung index is obviously different from that of a model control group (P < 0.05). The traditional Chinese medicine compound composition in the embodiment 3 is the optimal embodiment, the lung index inhibition rate of the traditional Chinese medicine compound composition is close to that of a positive medicine ribavirin granule, is slightly lower than that of the ribavirin granule, but is greatly higher than that of the children's quick-heat-clearing oral liquid group in the comparative example 2, and the traditional Chinese medicine compound composition has a good effect of resisting the infection of the H1N1 influenza virus FM1 strain. It is worth mentioning that the preparation method of the traditional Chinese medicine extract of the comparative example 5 is different from the preparation method of the invention in that the artemisia apiacea of the comparative example 5 is extracted by 65% ethanol, and it can be seen that the antiviral effect in the traditional Chinese medicine compound composition is reduced only by changing the extraction mode, because the effect of the water-soluble components in the artemisia apiacea extract on the upper respiratory tract infection symptoms is more remarkable than that of the fat-soluble components.

Test example 2 therapeutic action of the Chinese herbal compound composition of the invention on pneumonia model of respiratory syncytial virus infected ICR mice

A respiratory syncytial virus infected mouse pneumonia model is adopted, a lung index and a lung inhibition rate are used as indexes, 90 ICR mice (license number: SCXK (Jing) 2016-0011) with the weight of 12 +/-1 g are taken, and the sex are randomly divided into 9 groups according to the weight grades, namely a normal control group, a model control group, example 1-4 dose groups, comparative example 1-2 dose groups and comparative example 5 dose groups. Each group had 10. Wherein, the comparative example 1 is a positive drug ribavirin granule, the clinical dosage of human is 450mg/60kg/d, and the equivalent dosage converted into mouse is 82.5 mg/kg; the dosage of examples 1-4 and comparative example 5 is 22g crude drug/kg comparative example 2 is the infantile instant fever clearing oral liquid, and the dosage is 16.5 mL. Except for the normal control group, the mice were lightly anesthetized with ether at 10000TCID₅₀Respiratory syncytial virus droplets were nasally infected, 30. mu.l each. The administration is started on the day of infection, and the administration is performed by intragastric administration at a dose of 0.2ml/10g each time, 1 time per day for 4 consecutive days, and the intragastric administration is performed by distilled water in a normal control group and a model control group under the same condition. Weighing on day 5, dissecting the mice, taking lungs, weighing the lungs, calculating the lung index and lung index inhibition rate, and leaving the specimen for determining the viral load in lung tissues. Results statistical treatment was performed using an interclass comparison t-test, with lung index and lung index inhibition as shown in formulas (I) and (II), respectively, and the test results as shown in table 2:

TABLE 2 therapeutic effect on respiratory syncytial virus infection ICR mouse model of pneumonia

As can be seen from Table 2, after the mice are infected by the respiratory syncytial virus, the lung index of the mice is obviously increased, and the mice have significant difference (P <0.01) compared with a normal control group; after the traditional Chinese medicine compound composition provided by the invention and given by the doses of 1-4 on the day of infection starts to be treated for 4 days, the lung index is obviously reduced (P < 0.05). The traditional Chinese medicine compound composition in the embodiment 3 is the optimal embodiment, and the lung index inhibition rate of the traditional Chinese medicine compound composition is close to that of a positive medicine ribavirin granule, is slightly lower than that of the positive medicine ribavirin granule, and is greatly higher than that of the children's quick-heat-clearing oral liquid group in the comparative example 2 and the comparative example 5. Since the compound Chinese medicinal composition of example 3 is the most preferred embodiment of the present invention, the following experiments are conducted only with the compound Chinese medicinal composition of example 3, to prove the beneficial effects thereof in preparing a medicament for treating upper respiratory tract infection.

Test example 3 death protection effect of the Chinese herbal compound composition of the invention on ICR mouse pneumonia model infected by H1N1 influenza virus FM1 strain

80 ICR mice (license number: SCXK (Jing) 2016-. Each group had 20. Wherein, the comparative example 1 is a positive drug ribavirin granule, the clinical dosage of human is 450mg/60kg/d, and the equivalent dosage converted into mouse is 82.5 mg/kg; comparative example 2 is the children's quick-heat clearing oral liquid, the dosage is 16.5 mL; the dose of example 3 was 22g crude drug/kg. Mice were lightly anaesthetized with ether, infected with 2 drops of LD50 influenza virus (FMI strain) each at 30. mu.l, administered on the day of infection, gavaged with 0.2ml/10g of body weight each time, 1 time per day for 5 consecutive days, and the model control group was gavaged with distilled water under the same conditions. The animals were observed for mortality within 2 weeks after infection and mortality, mortality protection, mean survival days and life extension were calculated. The mortality rate (III), the mortality-protective rate (IV) and the life-prolonging rate (V) were calculated, and the test results are shown in Table 3:

(Ⅲ)

(Ⅳ)

(Ⅴ)

TABLE 3 protection against death in ICR pneumonia model in mice infected with H1N1 influenza virus strain FM1

Note: p <0.01, P <0.05 compared to model control group

As shown in Table 3, within 2 weeks of infection of mice with influenza A H1N1 strain FM1 virus, the mortality of the animals in the model group is 90%, and the average survival days is only 7.65 days; when the traditional Chinese medicine compound composition in the embodiment 3 of the invention is taken therapeutically, the death rate of mice is obviously reduced and the death protection rate is 38.89% after 5 days of continuous administration, and the significant difference (P <0.05) is compared with a model control group, which shows that the survival days of the mice can be prolonged, and the significant difference (P <0.01) is compared with the model control group, the life prolonging rates are respectively 41.83%, and are much higher than the children's quick-heat clearing oral liquid in the comparative example 2.

Test example 4 death protection effect of the traditional Chinese medicine compound composition of the invention on ICR mice pneumonia model infected with H1N1 influenza virus PR8 strain

80 ICR mice (license number: SCXK (Jing) 2016-. Each group had 20. Wherein, the comparative example 1 is a positive drug ribavirin granule, the clinical dosage of human is 450mg/60kg/d, and the equivalent dosage converted into mouse is 82.5 mg/kg; comparative example 2 is the children's quick-heat clearing oral liquid, the dosage is 16.5 mL; the dose of example 3 was 22g crude drug/kg. Mice were lightly anaesthetised with ether and infected nasally with 2 drops of LD50 influenza virus (PR8 strain) 30. mu.l each. Administration was started on the day of infection, and each group of mice was gavaged with 0.2ml/10g each time, 1 time per day for 5 consecutive days, and the model control group was gavaged with distilled water under the same conditions. The animals were observed for mortality within 2 weeks after infection and mortality, mortality protection, mean survival days and life extension were calculated. Mortality, mortality protection and Life prolongation were calculated according to formulas (III), (IV) and (V).

TABLE 4 protection against H1N1 influenza PR8 strain infecting ICR mouse model of pneumonia

Note: p <0.01, P <0.05 compared to model control group

As shown in Table 4, within 2 weeks of infection of mice with influenza A virus PR8 strain H1N1, the mortality of the animals in the model group is 90%, and the average survival days is only 7.45 days; when the traditional Chinese medicine compound composition of the embodiment 3 of the invention is taken therapeutically, the death rate of the mice is obviously reduced after 5 continuous days, the survival days of the mice can be prolonged, and compared with a model control group, the traditional Chinese medicine compound composition has significant difference (P is less than 0.05), and the life prolonging rate reaches 26.17%.

Test example 5 influence of the Chinese herbal compound composition of the present invention on viral load in lung tissue of virus-infected mouse

5.1 the material taking method comprises the following steps: the specimens left in test example 1 and test example 2 for determining the viral load in lung tissue.

5.2 primer design and Synthesis:

the upstream and downstream primers for the influenza virus (H1N1) gene sequence were:

5'-CTTCTAACCGAGGTCGAAACGTA-3' and

5'-GGTGACAGGATTGGTCTTGTCTTTA-3'；

the upstream and downstream primers aiming at the gene sequence of the respiratory syncytial virus are respectively as follows:

5'-GCTCCGTTATCACATCTC-3' and 5'-GTCTTTATGATTCCACGATT-3';

primers for the gene sequence of the housekeeping gene GAPDH (total RNA usage was monitored to eliminate errors caused by loading between samples) were: 5'-GGTGAAGGTCGGTGTGAACG-3', and 5'-CTCGCTCCTGGAAGATGGTG-3'.

5.3Real-time RT-PCR amplification: after the TRIzol reagent is used for extracting RNA in lung tissues, a one-step real-time fluorescence RT-PCR method is adopted to perform reverse transcription reaction and PCR reaction in the same system, the reaction volume is 20 mul, and the reaction system comprises: 2 μ l of sample RNA, 0.8 μ l of each of the upstream and downstream primers, 0.8 μ l of reverse transcriptase, 10 μ l of 2-fold buffer, and 5.6 μ l of RNase-free water. The reaction conditions are as follows: reverse transcription at 42 ℃ for 5min, pre-denaturation at 95 ℃ for 10sec, 1 cycle; denaturation at 95 ℃ for 5sec, annealing at 60 ℃ for 34sec, for 40 cycles. And (3) performing melting curve analysis after the reaction is finished so as to identify the specificity of the PCR product. Ct (threshold of cycle) values of each test sample during PCR were analyzed using the PikoReal Real-Time PCR System software.

5.4 result calculation method and statistical method: this experiment uses a relative quantitative method, with GAPDH as the internal control, and one sample (Con) was selected as the Calibrator, calculated as follows:

Con△Ct＝Con Ct－Con GAPDH Ct

sample Δ Ct ═ sample Ct-sample GAPDH Ct

Sample delta Ct-Con delta Ct

2^-ΔΔCtIs the fold change in gene expression relative to Calibrator for each treatment group.

Change in relative content of 2^-ΔΔCt

The viral load inhibition was calculated according to formula (VI).

(Ⅵ)

Table 5 Effect on viral load in lung tissue of H1N1 influenza virus strain FM1 infected mice

Note: compared with the model control group,^##P<0.01，**P<0.01

as shown in table 5, after mice were infected with influenza a H1N1 strain FM1 virus, significant viral gene expression was observed in lung tissues; after the traditional Chinese medicine compound composition provided by the embodiment 3 of the invention is given on the day of infection, the virus expression amount can be obviously reduced after 4 days of treatment, the obvious difference (P <0.05) is obtained compared with a model control group, the inhibition rate is 80.36%, and the inhibition rate is far higher than that of an oral liquid for quickly clearing away heat from children, so that the traditional Chinese medicine compound composition provided by the invention has a good antiviral effect, although the effect is not as good as that of a positive medicine ribavirin granule, the effect is close to that of the positive medicine ribavirin granule, and compared with a western medicine positive medicine ribavirin, the traditional Chinese medicine compound composition provided by the invention is safer.

TABLE 6 Effect on viral load in lung tissue of respiratory syncytial Virus-infected mice

Note: compared with the model control group,^##P<0.01，**P<0.01

as shown in table 6, after infection of mice with respiratory syncytial virus, there was significant viral gene expression in lung tissue; after the traditional Chinese medicine compound composition provided by the embodiment 3 of the invention is administered on the infection day, the virus expression level can be obviously reduced after 4 days of treatment, the significant difference (P <0.05) is obtained compared with a model control group, the inhibition rate is 71.50%, and the traditional Chinese medicine compound composition has a good effect of resisting respiratory syncytial virus.

Test example 6 antipyretic, analgesic and anti-inflammatory test of the Chinese medicinal Compound composition of the present invention

6.1 test on antipyretic Effect of the Chinese medicinal Compound composition

The yeast-induced rat fever model proves that the Chinese medicinal compound composition has an antipyretic effect experiment. The experimental procedure was as follows: taking 74 SD rats with half male and half female and 50-60 g (young), and carrying out adaptive feeding and adaptive anal temperature measurement on animals. The body temperature (anal temperature, depth of the thermometer inserted into the anus is 2cm) is measured once a day in a quiet environment for 2 consecutive days, the body temperature of the animal is measured twice the day of the experiment, and the average temperature is taken as the basic body temperature. Afterwards, 15% dry yeast suspension was used for back subcutaneous injection (2ml/100g body weight) for pyrogenicity, after 3.5 hours the body temperature was measured, and animals with a body temperature rise of between 0.8-2.0 ℃ were taken for the experiment. The body temperature rise values are randomly grouped into 3 groups, and each group contains 12 animals, namely a model control group, an example 3 dose group and a comparative example 3 dose group. Wherein, the dosage of the positive drug aspirin in comparative example 3 is 0.18g/kg body weight, and the dosage of the dosage group in example 3 is 8.16g crude drug/kg. Each group has 12 female and male halves. The drug was administered by gavage, 1ml/100g body weight, and the same volume of drinking water was administered to the experimental animals by gavage in the model control group. The body temperature was measured once after 1, 2, 4 hours after administration, the measured body temperature values (deg.C) at different time points were recorded and compared with the basal body temperature, and the difference value of body temperature change (DeltaT, deg.C) at each time point was calculated, and the test results are shown in tables 7 and 8. The experiment was repeated once in the same manner, and the results are shown in tables 9 and 10 (the increase in body temperature of 2.3 ℃ after yeast in 1 male animal was included in the experiment and was randomly assigned to the low dose group of example 3).

Table 7 effect on yeast-induced rat fever body temperature in the first experiment (c,

)

note: p <0.05, P <0.01 compared to model control.

Table 8 effect on yeast-induced rat fever body temperature for the first experiment (Δ T c,

)

note: p <0.05, P <0.01 compared to model control.

As shown in tables 7 and 8, in the yeast-induced rat fever model, compared with the model control group, the body temperature value and the body temperature change difference of the traditional Chinese medicine compound composition of the embodiment 3 of the invention are both reduced 2 hours after the drug administration, and the difference has statistical significance (P <0.05 and P < 0.01).

Table 9 effect on yeast-induced fever body temperature in rat second experiment (c,

)

note: p <0.05, P <0.01 compared to model control.

Table 10 effect on yeast-induced rat fever body temperature for the second experiment (Δ T c,

)

note: p <0.01, P <0.05 compared to model control.

As shown in tables 9 and 10, in the yeast-induced rat fever model, compared with the model group, the body temperature value of the dose group of the traditional Chinese medicine compound composition of the embodiment 3 of the invention is reduced 1 hour after the drug administration, and the difference has statistical significance (P < 0.05).

6.2 analgesic Effect test of the Chinese medicinal Compound composition

A mouse acetic acid writhing model proves that the traditional Chinese medicine compound composition has an analgesic effect. The experimental procedure was as follows: 30 ICR mice with half male and female parts and 13-15 g (young) weights are randomly grouped according to the weights, and 3 groups are respectively a model control group, a traditional Chinese medicine compound composition dose group in embodiment 3 of the invention and a proportional 4 dose group. Wherein, the comparative example 4 group is diclofenac sodium, and the dosage is 0.008 g/kg; example 3 the composition dose was 10.88g crude drug/kg; each group comprises 10 male and female halves. The administration was by gavage, 0.2ml/10g body weight, and the same volume of drinking water was administered to the experimental animals by gavage in the model control group once a day for 3 consecutive days. Intraperitoneal injection of 0.8% acetic acid at 1 hour after the last dose, 0.1ml/10g body weight, and body writhing times (abdominal contraction, concavity, trunk hind limb extension, body twist) of mice within 20 minutes after acetic acid injection were observed and recorded for comparison among groups.

TABLE 11 influence on acetic acid-induced writhing response in mice (writhing frequency)

Note: p <0.05 compared to model control.

As shown in table 11, compared with the model control group, the number of writhing times of the dosage group of the compound traditional Chinese medicine composition in example 3 is reduced, and the difference has statistical significance (P <0.05), which suggests that the compound traditional Chinese medicine composition in example 3 has an analgesic effect on the writhing response of the mice caused by the pain of the acetic acid.

6.3 anti-inflammatory effect experiment of the traditional Chinese medicine compound composition

6.3.1 Effect on acetic acid-induced increase in Permeability of capillary vessels in mouse peritoneal cavity

30 ICR mice with half male and female bodies and 13-15 g (young) weights are randomly grouped according to the weights, and 3 groups are respectively a model control group, a traditional Chinese medicine compound group dose group in the embodiment 3 of the invention and a proportional 4 dose group. Wherein, the comparative example 4 group is diclofenac sodium, and the dosage is 0.008 g/kg; example 3 the composition dose was 10.88g crude drug/kg; each group comprises 10 male and female halves. Gavage was performed, 0.2ml/10g body weight, and the control group was gavage with the same volume of drinking water for the experimental animals once a day for 3 consecutive days. After 1 hour of the last dose, 0.5% evans solution was injected into the tail vein, 0.1ml/10g of body weight, 0.8% acetic acid was injected into the abdominal cavity after 10 minutes, 5 ml/physiological saline was injected into the abdominal cavity after 10 minutes, the mice were immediately sacrificed, the abdomen was gently kneaded 50 times, the abdominal skin was cut open, the abdominal cavity was opened, the washing solution was aspirated by a pipette, centrifuged (3000rpm, 15 minutes), and the optical density (OD value) was measured at a wavelength of 590nm using a multifunctional microplate reader for comparison between groups.

TABLE 12 Effect on acetic acid-induced increase in the permeability of the capillary vessels in the abdominal cavity of mice

Note: p <0.01 compared to model control group.

As shown in table 12, compared with the model control group, the OD value of the peritoneal washing solution in the dosage group of the compound traditional Chinese medicine composition in example 3 was reduced, and the difference was statistically significant (P <0.05), suggesting that the compound traditional Chinese medicine composition in example 3 has an anti-inflammatory effect on the inflammatory reaction of acetic acid-induced increase in permeability of the peritoneal capillaries of mice.

It will be appreciated by those skilled in the art that the above embodiments are merely illustrative of the principles and utilities of the present invention and are not intended to limit the invention. Any person skilled in the art can modify or change the above-mentioned embodiments without departing from the spirit and scope of the present invention. Accordingly, it is intended that all equivalent modifications or changes which can be made by those skilled in the art without departing from the spirit and technical spirit of the present invention be covered by the claims of the present invention.

Claims

1. The traditional Chinese medicine compound composition is characterized by comprising the following components in parts by weight: 20-40 parts of a volatile oil inclusion compound, 200-300 parts of a traditional Chinese medicine extract, 0.5-6 parts of a sweetening agent, 3-10 parts of magnesium stearate, 2-10 parts of essence and 1000 parts of sucrose powder, wherein the volatile oil inclusion compound is obtained by including elsholtzia and patchouli oily extracts by a cyclodextrin colloid milling method, and the traditional Chinese medicine extract is a water-decocted extract of scutellaria baicalensis, fructus forsythiae, honeysuckle stem, wild chrysanthemum, sweet wormwood herb and bitter trifoliate;

the traditional Chinese medicine compound composition can obviously reduce the expression level of the respiratory syncytial virus;

the volatile oil inclusion compound comprises volatile oil and cyclodextrin, the weight ratio of the volatile oil to the cyclodextrin is 1: 10-20, wherein the volatile oil comprises 400-650 parts by weight of elsholtzia and 400-600 parts by weight of pogostemon cablin;

the traditional Chinese medicine extract comprises the following raw materials in parts by weight: 350-600 parts of scutellaria baicalensis, 400-600 parts of fructus forsythiae, 700-900 parts of honeysuckle stem, 400-650 parts of wild chrysanthemum flower, 300-600 parts of sweet wormwood and 400-600 parts of thin evodia;

the sweetener is sucralose or aspartame;

the sucrose powder is a diluent.

2. The traditional Chinese medicine compound composition according to claim 1, which is characterized by comprising the following components in parts by weight: 30-35 parts of volatile oil inclusion compound, 250-300 parts of traditional Chinese medicine extract, 1.2-2 parts of sweetening agent, 5-7 parts of magnesium stearate, 4-5 parts of essence and 1000 parts of sucrose powder.

3. The compound traditional Chinese medicine composition of claim 1, wherein the cyclodextrin is beta-cyclodextrin.

4. The compound traditional Chinese medicine composition according to claim 1, wherein the traditional Chinese medicine extract comprises the following raw materials in parts by weight: 400-500 parts of scutellaria baicalensis, 450-550 parts of fructus forsythiae, 750-850 parts of honeysuckle stem, 500-550 parts of wild chrysanthemum flower, 450-520 parts of sweet wormwood herb and 450-550 parts of trifoliate bitter herb.

5. The compound traditional Chinese medicine composition of claim 1, wherein the sucrose powder has a mesh size of 80-120 meshes.

6. The preparation method of the traditional Chinese medicine compound composition according to claim 1, which is characterized by comprising the following steps: taking the sweetening agent, the magnesium stearate, the volatile oil inclusion compound, the traditional Chinese medicine extract, the essence and the sucrose powder according to the formula ratio, mixing uniformly, and performing dry pressing and granulation to obtain the compound.

7. The preparation method of the traditional Chinese medicine compound composition according to claim 6, wherein the preparation method of the volatile oil clathrate compound comprises the following steps: s1, adding water, and extracting herba Moslae and herba Agastaches by steam distillation to obtain volatile oil; s2, including the volatile oil obtained in the step S1 with cyclodextrin, drying and crushing to obtain a volatile oil inclusion compound; s3, decocting fructus forsythiae, honeysuckle stem, wild chrysanthemum flower, sweet wormwood herb, thin evodia leaf and radix scutellariae with water to obtain decoction, filtering the decoction, and concentrating the decoction to obtain extract with the relative density of 1.10-1.14 at 50 ℃; s4, adding ethanol into the extract obtained in the step S3, standing, filtering, concentrating to form thick paste with the relative density of 1.25-1.30 at 50 ℃, drying, and crushing to obtain the traditional Chinese medicine extract.