CN110801486B

CN110801486B - Traditional Chinese medicine compound preparation and preparation method and application thereof

Info

Publication number: CN110801486B
Application number: CN201911118087.1A
Authority: CN
Inventors: 徐培平; 王惠娴; 叶毅
Original assignee: Guangzhou University of Traditional Chinese Medicine
Current assignee: Guangzhou University of Traditional Chinese Medicine
Priority date: 2019-11-14
Filing date: 2019-11-14
Publication date: 2021-12-21
Anticipated expiration: 2039-11-14
Also published as: CN110801486A

Abstract

The invention discloses a traditional Chinese medicine compound preparation, which comprises the following raw material medicines in parts by weight: 5-20 parts of poria cocos, 5-10 parts of liquorice, 5-20 parts of fructus aurantii, 5-20 parts of platycodon grandiflorum, 10-20 parts of radix bupleuri, 15-50 parts of gypsum, 10-20 parts of rhizoma anemarrhenae, 10-20 parts of radix peucedani, 10-20 parts of notopterygium root, 10-20 parts of rhizoma cimicifugae, 10-20 parts of radix sileris, 10-20 parts of schizonepeta, 10-20 parts of ligusticum wallichii, 10-30 parts of radix puerariae, 5-10 parts of mint, 15-30 parts of honeysuckle, 15-30 parts of fructus forsythiae, 10-20 parts of agastache rugosus, 5-15 parts of ephedra and 10-30 parts of rhizoma atractylodis. The traditional Chinese medicine compound preparation has the effects of expelling pathogenic factors, relieving exterior syndrome, ventilating lung, eliminating dampness, detoxifying, clearing lung and the like, can be used for treating viral pneumonia caused by influenza A, and has obvious curative effects on typical symptoms of influenza A, such as fever, throat discomfort or pain, cough and the like. The traditional Chinese medicine compound preparation takes common traditional Chinese medicinal materials as raw materials, exerts the advantage of low toxic and side effects of the traditional Chinese medicines, and has clinical application value of safety, effectiveness, low price and easy wide popularization.

Description

Traditional Chinese medicine compound preparation and preparation method and application thereof

Technical Field

The invention relates to the technical field of medicines, in particular to a traditional Chinese medicine compound preparation and a preparation method and application thereof.

Background

Influenza (hereinafter referred to as influenza) is an acute respiratory infectious disease caused by influenza virus, has the characteristics of strong infectivity, high morbidity, wide epidemic range, high mortality and the like, and is listed as one of the worldwide infectious diseases which cannot be effectively controlled at present. China is a frequently-occurring country of influenza, and the influenza is outbreaked almost every year, so that a plurality of critically ill patients and death cases are caused, and the health, life, learning, economy and other aspects of human beings are greatly influenced. Influenza viruses are classified into three types, namely A (A), B (B) and C (C), wherein the A virus often has antigenic variation, is high in infectivity, is rapidly transmitted, is very easy to pandemic, and is the main virus type for influenza. Influenza often causes viral pneumonia, which is the result of the downward spread of viral infection. Vaccines and antiviral drugs are effective means for preventing and treating influenza, but vaccines are often subject to the possibility of failure due to viral variation. The most preferred antiviral drug for treating influenza is oseltamivir phosphate capsules, and the limitations of drug resistance and drug toxic and side effects caused by virus variation are also faced. Therefore, a medicament for preventing and treating influenza diseases, which is safe and effective, has small toxic and side effects and low cost, is clinically needed.

The traditional Chinese medicine considers that the influenza belongs to the category of external epidemic febrile diseases, and the disease location is mainly lung and can reach the stomach and intestine. The pathogenic factors are exogenous warm pathogenic factors, and the pathogenic factors of lung defense are transmitted into the interior along the course of disease, and then they are transmitted to the qi system directly to the lung defense and the stomach and intestine. From the perspective of traditional Chinese medicine, "lung and large intestine are exterior and interior", lung and large intestine are not only physiologically related but also pathologically affected, and diseases of lung disease and intestine or intestinal disease and lung and intestine can be transmitted and changed mutually, even malignant circulation is continuously formed. Influenza belongs to the category of exogenous febrile diseases in traditional Chinese medicine, and exogenous severe lung and intestine is an important method for treating the influenza by the traditional Chinese medicine. The lung governs skin and hair and the large intestine governs the conduction; the lung is the delicate organ, the surface of the sun is the fence of the whole body, which is the first barrier between the body and the outside world and is most vulnerable to the attack of six exogenous pathogens. After the lung is attacked by pathogenic factors, the function of dispersing and descending is abnormal, so that symptoms such as fever, aversion to cold, cough and asthma, sneeze, watery nasal discharge and the like appear; when the lung and large intestine are combined, pathogenic qi is transmitted through the exterior and interior, and then it is easy to transmit to the large intestine, resulting in constipation, diarrhea, loose stool, etc. with the lung heat moving to the intestine. Therefore, the onset of exogenous diseases can be both lung diseases and intestinal diseases, or both lung and intestinal diseases. In the early stage of influenza, the pathogenic factors of lung and stomach, damp toxin accumulation and lung dysfunction are manifested as fever, nasal discharge, nasal obstruction, cough and pharyngalgia; if the stomach and intestine are invaded, the stomach and intestine disharmony occurs, and the qi movement is lost and declined, nausea, vomiting, abdominal pain, diarrhea and watery stool occur; further development of the medicine causes the invasion of toxic pathogen, lung qi stagnation and lung collaterals injury, and viral pneumonia symptoms such as high fever, dyspnea, tachypnea, constipation and the like are seen.

Disclosure of Invention

In order to overcome the defects in the prior art, the invention aims to provide a traditional Chinese medicine compound preparation as well as a preparation method and application thereof. The invention discloses a compound traditional Chinese medicine preparation, which is prepared by integrating classical famous formulas of Jingfang Baidu powder, Maxingshigan decoction, Yinqiao powder, cimicifuga foetida and kudzuvine root decoction, wrinkled Gianthyssop vital energy powder and Baihu decoction according to the pathogenesis of influenza and the theory of 'external infection with severe lung and intestine' of traditional Chinese medicine, on the basis of clinical and experimental research results.

In order to realize the purpose, the invention adopts the technical scheme that:

a traditional Chinese medicine compound preparation comprises the following raw material medicines in parts by weight: 5-20 parts of poria cocos, 5-10 parts of liquorice, 5-20 parts of fructus aurantii, 5-20 parts of platycodon grandiflorum, 10-20 parts of radix bupleuri, 15-50 parts of gypsum, 10-20 parts of rhizoma anemarrhenae, 10-20 parts of radix peucedani, 10-20 parts of notopterygium root, 10-20 parts of rhizoma cimicifugae, 10-20 parts of radix sileris, 10-20 parts of schizonepeta, 10-20 parts of ligusticum wallichii, 10-30 parts of radix puerariae, 5-10 parts of mint, 15-30 parts of honeysuckle, 15-30 parts of fructus forsythiae, 10-20 parts of agastache rugosus, 5-15 parts of ephedra and 10-30 parts of rhizoma atractylodis.

Preferably, the traditional Chinese medicine compound preparation comprises the following raw material medicines in parts by weight: 10 parts of poria cocos, 5 parts of liquorice, 10 parts of fructus aurantii, 10 parts of platycodon grandiflorum, 10 parts of radix bupleuri, 30 parts of gypsum, 10 parts of rhizoma anemarrhenae, 10 parts of radix peucedani, 10 parts of notopterygium root, 10 parts of rhizoma cimicifugae, 10 parts of radix sileris, 10 parts of schizonepeta, 10 parts of ligusticum wallichii, 15 parts of radix puerariae, 5 parts of mint, 15 parts of honeysuckle, 15 parts of fructus forsythiae, 15 parts of agastache rugosus, 10 parts of ephedra and 15 parts of rhizoma atractylodis.

In the above raw materials, Poria is dried sclerotium of Wolf of Poria cos (Schw.) of Polyporaceae; the Glycyrrhrizae radix is dried root and rhizome of Glycyrrhiza uralensis Fisch, Glycyrrhiza inflata Bat, or Glycyrrhiza glabra L of Leguminosae; the fructus Aurantii is dried immature fruit of Citrus aurantium L. of Rutaceae and its cultivar; the radix Platycodi is dried root of Platycodon grandiflorus (Jacq.) A.Dc. of Campanulaceae; bupleuri radix is dried root of Bupleurum scorzonerifolium or Bupleurum scorzonerifolium of Umbelliferae; the gypsum is mineral containing hydrated calcium sulfate (CaSO4 & 2H 2O); rhizoma anemarrhenae is dried rhizome of rhizoma anemarrhenae of Liliaceae; radix Peucedani is dried root of Peucedanum praeruptorum Dunn of Umbelliferae; notopterygii rhizoma is root and rhizome of Umbelliferae family plant Notopterygii rhizoma, Notopterygium forbesii or Notopterygii rhizoma; the cimicifugae rhizoma is rhizome of Cimicifuga racemosa, Cimicifuga dahurica or Cimicifuga racemosa of Ranunculaceae and Cimicifuga genus; radix Saposhnikoviae is dried root of radix Saposhnikoviae belonging to Umbelliferae; herba Schizonepetae is dried aerial part of herba Schizonepetae of Labiatae, Schizonepeta tenuifolia Briq; rhizoma Ligustici Chuanxiong is rhizome of rhizoma Ligustici Chuanxiong of family Hippopotaceae; radix Puerariae is dried root of Pueraria lobata Ohwi of Leguminosae; herba Menthae is whole plant or leaf of herba Menthae of Labiatae; flos Lonicerae is flower bud of Lonicera Japonica, Lonicera japonica, and Lonicera fulvidraco; fructus forsythiae is fruit of Vahl, Forsythia suspensa (Thunb.) of Oleaceae; herba Agastaches is herba Agastaches of Labiatae or herba Agastaches whole plant; herba Ephedrae is the herbaceous stem of Ephedra sinica Stapf, Ephedra equiseti Maxim or Merrea intermedia of Ephedraceae; rhizoma Atractylodis is rhizome of Atractylodes lancea or Atractylodes chinensis of Compositae.

Preferably, the traditional Chinese medicine compound preparation is decoction, granules, capsules, tablets or pills.

When the Chinese medicinal compound preparation is decoction, the preparation method comprises the following steps: (1) mixing Poria, Glycyrrhrizae radix, fructus Aurantii, radix Platycodi, bupleuri radix, rhizoma anemarrhenae, radix Peucedani, Notopterygii rhizoma, cimicifugae rhizoma, radix Saposhnikoviae, herba Schizonepetae, rhizoma Ligustici Chuanxiong, radix Puerariae, flos Lonicerae, fructus forsythiae, herba Agastaches, herba Ephedrae and rhizoma Atractylodis, and soaking in water; (2) decocting gypsum in water for 30min, preferably, the water amount is about 2 times of that of gypsum, adding the medicinal materials and the water solution in the step (1), boiling with strong fire, decocting with slow fire for 25min, adding mint, continuously decocting for 5min, filtering, adding water into filter residues, decocting for 15-20min, preferably, the water amount is about 1 time of that of the filter residues, filtering, and combining the two filtrates to obtain the traditional Chinese medicine compound preparation of decoction. Preferably, in the step (1), the water surface is 2-3cm higher than the medicine surface when the medicine is soaked in water, and the soaking time is 1 h.

When the traditional Chinese medicine compound preparation is granules, capsules, tablets or pills, the preparation method comprises the following steps: weighing raw materials in proportion, adding water for first decoction, filtering, adding water to residue for second decoction, filtering, mixing filtrates, concentrating the filtrate for the first time, precipitating with ethanol, filtering to remove supernatant, recovering ethanol, concentrating for the second time to obtain extract, adding adjuvants, and making into granule, capsule, tablet or pill. The used auxiliary materials are common auxiliary materials in pharmacy, and are not described again. Preferably, the water adding amount of the first decoction is 10 times of the volume of the raw material medicines, and the decoction time is 30 min; the water adding amount of the second decoction is 5 times of the volume of the filter residue, and the decoction time is 30 min; the first concentration is concentrated into concentrated solution with the relative density of 1.1-1.2 at normal temperature; the alcohol precipitation is to add an ethanol solution with the mass percentage concentration of more than 95 percent so that the alcohol content of the concentrated solution reaches 60 percent, and the alcohol precipitation time is 48 hours; the second concentration is concentrated into extractum with the relative density of 1.3-1.4 at normal temperature.

The traditional Chinese medicine compound preparation is prepared from poria cocos, liquorice, fructus aurantii, platycodon grandiflorum, radix bupleuri, gypsum, rhizoma anemarrhenae, radix peucedani, notopterygium root, rhizoma cimicifugae, radix sileris, schizonepeta, ligusticum wallichii, radix puerariae, mint, honeysuckle, fructus forsythiae, agastache rugosus, ephedra and rhizoma atractylodis. In the prescription, herba schizonepetae, radix sileris, notopterygium root, ephedra herb and wrinkled gianthyssop herb are used as main medicines for relieving exterior syndrome and eliminating dampness with pungent-warm property; radix bupleuri, rhizoma cimicifugae, radix puerariae and mint are used as ministers to strengthen wind dispelling and exterior syndrome relieving; rhizoma atractylodis is used for dispelling wind and eliminating dampness, rhizoma ligustici wallichii is used for activating blood circulation, dispelling wind and relieving pain, flos lonicerae, fructus forsythiae, gypsum and rhizoma anemarrhenae are used for clearing heat and removing toxicity, radix peucedani and platycodon grandiflorum are used for dispersing lung qi to eliminate phlegm, fructus aurantii is used for regulating qi and relieving epigastric distention, and poria cocos is used for removing dampness; licorice root, radix Glycyrrhizae coordinates the principal drugs, acting as a guide for relieving spasm and cough. The medicines cooperate to achieve the effects of dispelling wind, relieving exterior syndrome, eliminating dampness, clearing heat and removing toxicity.

The Chinese medicinal compound preparation has the effects of expelling pathogenic factors, relieving exterior syndrome, dispersing lung qi, eliminating dampness, removing toxic substance, clearing lung-heat, and the like, and can be used for treating influenza and viral pneumonia thereof. In the present invention, the influenza includes influenza a; the viral pneumonia comprises but is not limited to pneumonia induced by influenza A virus, and can also be used for viral pneumonia induced by other viruses.

Proved by influenza A virus infection viral pneumonia model tests, the traditional Chinese medicine compound preparation has the drug effects of remarkably increasing the survival rate of virus-infected mice, improving the weight, reducing the inflammatory injury of the lung and inhibiting the level of inflammatory cytokines of lung tissues, and can remarkably treat the acute lung injury induced by influenza viruses.

The invention also provides a medicine for treating influenza and viral pneumonia, which contains the traditional Chinese medicine compound preparation, wherein the influenza is influenza A, and the viral pneumonia is pneumonia induced by influenza A virus.

The invention has the beneficial effects that: the traditional Chinese medicine compound preparation has the effects of expelling pathogenic factors, relieving exterior syndrome, ventilating lung, eliminating dampness, detoxifying, clearing lung and the like, can be used for treating viral pneumonia caused by influenza A, and has obvious curative effects on typical symptoms of influenza A, such as fever, throat discomfort or pain, cough and the like. The traditional Chinese medicine compound preparation takes common traditional Chinese medicinal materials as raw materials, exerts the advantage of low toxic and side effects of the traditional Chinese medicines, and has clinical application value of safety, effectiveness, low price and easy wide popularization.

Drawings

FIG. 1 shows the effect of the compound Chinese medicinal preparation of the present invention on the pulmonary index of mice infected with influenza A virus;

FIG. 2 shows the effect of the compound Chinese medicinal preparation of the present invention on the lung pathomorphology of mice infected with influenza A virus;

FIG. 3 shows the effect of the compound Chinese medicine preparation of the present invention on the titer of the lung virus of mice infected with influenza A virus;

FIG. 4 shows the effect of the compound Chinese medicinal preparation of the present invention on the lung cytokine of mice infected with influenza A virus;

FIG. 5 shows the survival protection effect of the compound Chinese medicinal preparation on mice infected with influenza A virus;

FIG. 6 shows the toxic effect of the compound Chinese medicinal preparation of the present invention on MDCK cells;

FIG. 7 shows the in vitro inhibitory activity of the compound Chinese medicinal preparation of the present invention against influenza virus strain H1N1/FM 1.

Detailed Description

To better illustrate the objects, aspects and advantages of the present invention, the present invention is further illustrated by the following examples. It is apparent that the following examples are only a part of the embodiments of the present invention, and not all of them. It should be understood that the embodiments of the present invention are only for illustrating the technical effects of the present invention, and are not intended to limit the scope of the present invention.

Example 1

The embodiment provides a traditional Chinese medicine compound preparation of decoction, which comprises the following components in part by weight: 10 g of tuckahoe, 5g of liquorice, 10 g of fructus aurantii, 10 g of platycodon grandiflorum, 10 g of radix bupleuri, 30 g of gypsum, 10 g of rhizoma anemarrhenae, 10 g of radix peucedani, 10 g of notopterygium root, 10 g of rhizoma cimicifugae, 10 g of radix sileris, 10 g of herba schizonepetae, 10 g of rhizoma ligustici wallichii, 15g of radix puerariae, 5g of mint, 15g of honeysuckle, 15g of fructus forsythiae, 15g of agastache rugosus, 10 g of ephedra and 15g of rhizoma atractylodis.

The preparation method of the traditional Chinese medicine compound preparation comprises the following steps: putting the rest medicinal materials except gypsum and mint into a medicine boiling marmite, adding cold water to submerge the medicine surface for 2-3cm, and soaking for 1 h; adding water (the amount of the added water is about 2 times that of the gypsum) into another pot of the gypsum, decocting for 30min, adding the soaked medicinal materials and the water solution, boiling with strong fire, decocting with slow fire for 25min, adding mint, continuing to decoct for 5min, filtering out the liquid medicine with gauze, adding water (the amount of the added water is about 1 time that of the unfiltered residue) into the filter residue, decocting for 15-20min (the embodiment is decocting for 15min), filtering out the liquid medicine, and combining the two liquid medicines to obtain the traditional Chinese medicine compound preparation of decoction.

Example 2

The embodiment provides a traditional Chinese medicine compound preparation of a tablet, which comprises the following components in part by weight: 15g of tuckahoe, 10 g of liquorice, 15g of fructus aurantii, 15g of platycodon grandiflorum, 15g of radix bupleuri, 45 g of gypsum, 15g of rhizoma anemarrhenae, 15g of radix peucedani, 15g of notopterygium root, 15g of rhizoma cimicifugae, 15g of radix sileris, 15g of herba schizonepetae, 15g of rhizoma ligustici wallichii, 20 g of radix puerariae, 10 g of mint, 20 g of honeysuckle, 20 g of fructus forsythiae, 20 g of agastache rugosus, 15g of ephedra and 20 g of rhizoma atractylodis.

The preparation method of the traditional Chinese medicine compound preparation comprises the following steps: adding water with the volume of 10 times of the bulk drugs into the bulk drugs, decocting for 30min for the first time, and filtering; adding water 5 times the volume of the residue into the residue, decocting for 30min, and filtering; mixing the two filtrates, concentrating the filtrate into concentrated solution with the relative density of 1.1-1.2 at normal temperature, adding ethanol solution with the mass percent concentration of more than 95% to ensure that the ethanol content of the concentrated solution reaches 60%, carrying out ethanol precipitation on the concentrated solution, filtering supernatant after 48h of ethanol precipitation, recovering ethanol, concentrating into extract with the relative density of 1.3-1.4 at normal temperature, carrying out spray drying, and adding dextrin and sucrose powder, wherein the weight ratio of the dextrin to the sucrose powder is as follows: dextrin: sucrose powder 1:1:3, mixing well, sieving with 60 mesh sieve to obtain granules, drying, tabletting, each tablet weight is 0.5 g.

The taking method of the traditional Chinese medicine compound preparation of the tablet comprises the following steps: 3 times daily, 3 tablets each time.

Example 3

The embodiment provides a Chinese herbal compound preparation of a soft capsule, which comprises the following components in part by weight: 20 g of tuckahoe, 10 g of liquorice, 20 g of fructus aurantii, 20 g of platycodon grandiflorum, 20 g of radix bupleuri, 50 g of gypsum, 20 g of rhizoma anemarrhenae, 20 g of radix peucedani, 20 g of notopterygium root, 20 g of rhizoma cimicifugae, 20 g of radix sileris, 20 g of herba schizonepetae, 20 g of rhizoma ligustici wallichii, 30 g of radix puerariae, 10 g of mint, 30 g of honeysuckle, 30 g of fructus forsythiae, 20 g of agastache rugosus, 15g of ephedra and 30 g of rhizoma atractylodis.

The preparation method of the traditional Chinese medicine compound preparation comprises the following steps: adding water 10 times the volume of the raw materials, decocting for 30min, and filtering; adding water 5 times the volume of the residue into the residue, decocting for 30min, and filtering; mixing the two filtrates, concentrating the filtrate to obtain concentrated solution with relative density of 1.1-1.2 at room temperature, adding ethanol solution with mass percent concentration of above 95% to make the ethanol content of the concentrated solution reach 60%, precipitating with ethanol for 48h, filtering to remove supernatant, recovering ethanol, concentrating to obtain extract with relative density of 1.3-1.4 at room temperature, spray drying, adding appropriate amount of soybean oil, soybean phospholipid, beeswax and polyethylene glycol to obtain suspension, and making into soft capsule by pressing method, wherein each capsule contains 0.5g of medicine.

The taking method of the traditional Chinese medicine compound preparation of the soft capsule comprises the following steps: the preparation is administered 2 granules 3 times a day.

Example 4

The embodiment provides a Chinese herbal compound preparation of a soft capsule, which comprises the following components in part by weight: 5g of tuckahoe, 5g of liquorice, 5g of fructus aurantii, 5g of platycodon grandiflorum, 10 g of radix bupleuri, 15g of gypsum, 10 g of rhizoma anemarrhenae, 10 g of radix peucedani, 10 g of notopterygium root, 10 g of rhizoma cimicifugae, 10 g of radix sileris, 10 g of herba schizonepetae, 10 g of rhizoma ligustici wallichii, 10 g of radix puerariae, 5g of mint, 15g of honeysuckle, 15g of fructus forsythiae, 10 g of agastache rugosus, 5g of ephedra and 10 g of rhizoma atractylodis.

Example 5

Inhibiting effect on pneumonia of influenza virus infected mice

BALB/C mice 60 (13-15g) were randomized into 6 groups of 10 per group by body weight: a normal control group; influenza a virus control group; the traditional Chinese medicine compound preparation comprises a high-dose group of 6g/kg, a medium-dose group of 3g/kg and a low-dose group of 1.5g/kg, and is prepared according to the prescription and the method of the embodiment 1, and is concentrated into 200mL of traditional Chinese medicine decoction; tamiflu group (75 mg/kg).

The mice of the other groups except the normal control group are anesthetized by ether and infected with 15LD by nasal drip ₅₀1/47/FM/H1N1 influenza virus liquid 50. mu.L, normal control group was treated with nasal drops of 50. mu.L physiological saline as control. The administration of the gavage was started 2 hours after the infection of the mice, and the normal control group and the virus control group were administered once a day with a constant volume of physiological saline (40mL/kg) for continuous administration for 4 days, and on the 5 th day after the infection, the animals were sacrificed and the lung weight and the body weight were measured. After the abdominal aorta is subjected to blood sampling, the chest is opened, the whole lung is taken out, the lung lesion degree is visually observed, the lung lesion degree is recorded, the lung lesion degree is cleaned by physiological saline, then residual saline is absorbed by clean filter paper, the wet weight is weighed, and the lung index is calculated. A part of the mouse lung was fixed in 10% paraformaldehyde solution and treated conventionally. HE staining and slicing. Pathological changes of lung tissues are observed, and a part of lung tissues are taken to detect the titers of cytokines and viruses. The experiment is carried out by the administration volume of 20mL/kg mouse body weight.

The results are as follows:

(1) lung index: on day four of viral infection, animals were weighed, lungs were weighed for routine treatmentLung wet weight; calculating lung index ═ lung wet weight (mg)/body weight (g)]X 100. The experimental result is shown in figure 1, compared with the virus control group, the traditional Chinese medicine compound preparation can obviously inhibit the increase of the pulmonary index (P) of the mouse<0.01). (note: compared to the virus control group,^*p<0.05,^**p<0.01，^***p<0.01)

(2) pathological organization of lung tissue: the HE results are shown in FIG. 2, and the lung tissue structure of the mice in the normal control group was normal, and no inflammatory lesions were observed. The lung tissues of the mice in the virus control group have inflammatory lesions with different degrees, a large amount of inflammatory cells infiltrate the alveolar wall, the alveolar wall is widened, the structure is unclear, and edema appears. The traditional Chinese medicine compound preparation can obviously improve the pneumonia pathology of mice infected by influenza virus. (note: compared to the virus control group,^*p<0.05,^**p<0.01，^***p<0.01)

(3) pulmonary viral load: a mouse right lung tissue sample (100mg) is taken, and the virus load in the lung tissue is determined by a real-time quantitative RT-PCR method. The experimental result is shown in fig. 3, compared with the virus control group, the traditional Chinese medicine compound preparation can obviously inhibit the virus titer rise (P) in the lung of the virus-infected mouse<0.05,P<0.01), which shows that the Chinese herbal compound preparation can effectively inhibit the replication of virus in the lung of a mouse. (note: compared to the virus control group,^*p<0.05,^**p<0.01，^***p<0.01)

(4) lung tissue cytokine: mouse lung homogenate, 3000rpm centrifugation for 15 minutes to harvest supernatant, using ELISA method for TNF-alpha, IL-4, IL-1 beta, IFN-gamma level. The results are shown in figure 4, compared with the virus control group, the traditional Chinese medicine compound preparation of the invention can obviously reduce the increase (P) of the levels of proinflammatory factors TNF-alpha, IL-4, IL-1 beta and IFN-gamma in the lung of a mouse<0.05 to 0.01). The Chinese medicinal compound preparation has obvious inhibition effect on the acute mouse pneumonia induced by the H1N1 influenza virus after being orally taken. (note: compared to the virus control group,^*p<0.05,^**p<0.01，^***p<0.01)

example 6

Experiment for survival protection of mice infected with influenza virus

BALB/C mice 60 (13-12g), experimental groups, infection dose and dosing schedule as in example 5; the mice of the other groups except the normal control group are anesthetized by ether and infected with 5LD by nasal drip ₅₀1/47/FM/H1N1 influenza virus liquid 50 μ L, normal control group nasal drip 50 μ L normal saline as control; the mice begin to be subjected to intragastric administration 2 hours after infection, normal control groups and virus control groups are subjected to intragastric administration of physiological saline (20mL/kg) with equal volume, administration is carried out once a day for 6 days continuously, the administration is stopped for 14 days, the survival number and death number of animals are recorded every day, and the life protection rate of the drug on the severe influenza infected mice is calculated.

Experimental results prove that after the traditional Chinese medicine compound preparation is orally taken, the survival rate of mice infected by influenza virus can be improved, the survival time of the mice is prolonged, and the traditional Chinese medicine compound preparation has the survival protection effect (figure 5, wherein (A) the survival rate of the mice, (B) the average survival time of the mice is compared with that of a virus control group,^*p<0.05,^**p<0.01，^***p<0.01)。

the experimental results are integrated, so that the traditional Chinese medicine compound preparation has a remarkable treatment effect on viral pneumonia induced by influenza virus H1N1, the survival rate of mice infected by the influenza virus can be remarkably improved, the pulmonary index (lung tissue wet weight/body weight ratio) and the virus titer are reduced, and the release of inflammatory cytokines in lungs is inhibited.

Example 7

Chinese medicinal compound preparation for inhibiting activity of influenza cells in vitro

Adding MDCK cell into Chinese medicinal compound preparation (0.625-20mg/mL) at 37 deg.C with 5% CO concentration₂The results of culturing under the conditions and examining the viability of the cells by the MTT method are shown in FIGS. 6 and 7. The compound traditional Chinese medicine preparation is prepared according to the prescription and the method of the embodiment 1, and is concentrated into 200mL of traditional Chinese medicine decoction.

The results show that the traditional Chinese medicine compound preparation has cytotoxicity TC₅₀11.4 mg/ml. MDCK cells are infected by 100TCID50 influenza virus H1N1/FM1 strain, and the traditional Chinese medicine compound preparation (0.625-5mg/mL) is added before (Pre-infection) the virus infection and at the same time (Simultaneous treatment) is added, and the half effective inhibition rate (EC) of the virus is added after the infection (Post treatment) when the medicine is added₅₀) Are respectively 1.25, 5.56 and>10 mg/ml. Therapeutic Indices (TI) of 3.47, 2.05 and<0.05. the traditional Chinese medicine compound preparation has better inhibition effect on influenza virus H1N1/FM1 when added with medicine before and during infection (the TI is more than 2, which indicates better treatment effect).

Finally, it should be noted that the above embodiments are only used for illustrating the technical solutions of the present invention and not for limiting the protection scope of the present invention, and although the present invention is described in detail with reference to the preferred embodiments, it should be understood by those skilled in the art that modifications or equivalent substitutions can be made on the technical solutions of the present invention without departing from the spirit and scope of the technical solutions of the present invention.

Claims

1. A traditional Chinese medicine compound preparation for treating influenza is characterized by comprising the following raw material medicines in parts by weight: 5-20 parts of poria cocos, 5-10 parts of liquorice, 5-20 parts of fructus aurantii, 5-20 parts of platycodon grandiflorum, 10-20 parts of radix bupleuri, 15-50 parts of gypsum, 10-20 parts of rhizoma anemarrhenae, 10-20 parts of radix peucedani, 10-20 parts of notopterygium root, 10-20 parts of rhizoma cimicifugae, 10-20 parts of radix sileris, 10-20 parts of schizonepeta, 10-20 parts of ligusticum wallichii, 10-30 parts of radix puerariae, 5-10 parts of mint, 15-30 parts of honeysuckle, 15-30 parts of fructus forsythiae, 10-20 parts of agastache rugosus, 5-15 parts of ephedra and 10-30 parts of rhizoma atractylodis.

2. The traditional Chinese medicine compound preparation for treating influenza according to claim 1, which is prepared from the following raw material medicines in parts by weight: 10 parts of poria cocos, 5 parts of liquorice, 10 parts of fructus aurantii, 10 parts of platycodon grandiflorum, 10 parts of radix bupleuri, 30 parts of gypsum, 10 parts of rhizoma anemarrhenae, 10 parts of radix peucedani, 10 parts of notopterygium root, 10 parts of rhizoma cimicifugae, 10 parts of radix sileris, 10 parts of schizonepeta, 10 parts of ligusticum wallichii, 15 parts of radix puerariae, 5 parts of mint, 15 parts of honeysuckle, 15 parts of fructus forsythiae, 15 parts of agastache rugosus, 10 parts of ephedra and 15 parts of rhizoma atractylodis.

3. The compound traditional Chinese medicine preparation for treating influenza according to claim 1, wherein the compound traditional Chinese medicine preparation is a decoction, and the preparation method comprises the following steps: (1) mixing Poria, Glycyrrhrizae radix, fructus Aurantii, radix Platycodi, bupleuri radix, rhizoma anemarrhenae, radix Peucedani, Notopterygii rhizoma, cimicifugae rhizoma, radix Saposhnikoviae, herba Schizonepetae, rhizoma Ligustici Chuanxiong, radix Puerariae, flos Lonicerae, fructus forsythiae, herba Agastaches, herba Ephedrae and rhizoma Atractylodis, and soaking in water; (2) decocting Gypsum Fibrosum in water for 30min, adding the medicinal materials and water solution of step (1), boiling with strong fire, decocting with slow fire for 25min, adding herba Menthae, decocting for 5min, filtering, decocting the residue with water for 15-20min, filtering, and mixing the filtrates to obtain the compound Chinese medicinal preparation.

4. The compound traditional Chinese medicine preparation for treating influenza according to claim 3, wherein in the step (1), the water surface is 2-3cm higher than the medicine surface when the compound traditional Chinese medicine preparation is soaked in water, and the soaking time is 1 h.

5. The compound traditional Chinese medicine preparation for treating influenza according to claim 1, wherein the compound traditional Chinese medicine preparation is granules, capsules, tablets or pills, and the preparation method comprises the following steps: weighing raw materials in proportion, adding water for first decoction, filtering, adding water to residue for second decoction, filtering, mixing filtrates, concentrating the filtrate for the first time, precipitating with ethanol, filtering to remove supernatant, recovering ethanol, concentrating for the second time to obtain extract, adding adjuvants, and making into granule, capsule, tablet or pill.

6. The compound traditional Chinese medicine preparation for treating influenza as claimed in claim 5, wherein the water adding amount of the first decoction is 10 times of the volume of the bulk drugs, and the decoction time is 30 min; the water adding amount of the second decoction is 5 times of the volume of the filter residue, and the decoction time is 30 min; the first concentration is concentrated into concentrated solution with the relative density of 1.1-1.2 at normal temperature; the alcohol precipitation is to add an ethanol solution with the mass percentage concentration of more than 95 percent so that the alcohol content of the concentrated solution reaches 60 percent, and the alcohol precipitation time is 48 hours; the second concentration is concentrated into extractum with the relative density of 1.3-1.4 at normal temperature.

7. The use of the compound Chinese medicinal preparation for treating influenza according to any one of claims 1 to 6 in the preparation of a medicament for treating influenza.

8. The use of claim 7, wherein the influenza is influenza A.

9. The use of the compound Chinese medicinal preparation for treating influenza according to any one of claims 1 to 6 in the preparation of a medicament for treating viral pneumonia.

10. The use of claim 9, wherein the viral pneumonia is influenza a virus-induced pneumonia.

11. A medicament for treating influenza, which is characterized by comprising the traditional Chinese medicine compound preparation for treating influenza as claimed in any one of claims 1 to 6.

12. The medicament of claim 11, wherein the influenza is influenza a.

13. A medicament for treating viral pneumonia, which is characterized by comprising the traditional Chinese medicine compound preparation for treating influenza as claimed in any one of claims 1 to 6.

14. The medicament of claim 13, wherein the viral pneumonia is influenza a virus-induced pneumonia.