CN111407808B

CN111407808B - Traditional Chinese medicine composition and preparation method and pharmaceutical application thereof

Info

Publication number: CN111407808B
Application number: CN202010119961.XA
Authority: CN
Inventors: 奚肇庆; 束雅春; 周贤梅; 刘志辉; 倪文澎; 王中秋; 汤忠华; 芮庆林; 周江; 姜誉弘
Original assignee: Jiangsu Kanion Pharmaceutical Co Ltd
Current assignee: Jiangsu Kanion Pharmaceutical Co Ltd
Priority date: 2020-02-26
Filing date: 2020-02-26
Publication date: 2022-12-09
Anticipated expiration: 2040-02-26
Also published as: CN111407808A

Abstract

The invention discloses an epidemic prevention traditional Chinese medicine composition which comprises the following components in parts by weight: 5 to 15 parts of notopterygium root, 5 to 30 parts of perilla leaf, 3 to 20 parts of fortune eupatorium herb, 5 to 12 parts of wrinkled gianthyssop herb, 3 to 15 parts of bran-fried rhizoma atractylodis, 3 to 15 parts of radix bupleuri, 3 to 12 parts of loquat leaf, 5 to 30 parts of sweet wormwood herb, 2 to 12 parts of mint, 3 to 15 parts of charred medicated leaven and 2 to 12 parts of liquorice. Compared with the prior art, the invention aims at the pathogenesis characteristics of viral upper respiratory tract infection diseases such as stagnation of damp toxin in the lung and dysfunction of the spleen and stomach, and establishes the dialectical treatment of the formula; the preparation process of the traditional Chinese medicine compound is reasonable in design, green and environment-friendly, can be prepared into various dosage forms, and is convenient to use. The composition has remarkable curative effect and wide market application prospect as determined by clinical tests.

Description

Traditional Chinese medicine composition and preparation method and pharmaceutical application thereof

Technical Field

The invention belongs to the traditional Chinese medicine technology, and particularly relates to a traditional Chinese medicine composition, and a preparation method and pharmaceutical application thereof.

Background

Since 12 th month in 2019, a plurality of novel patients with coronavirus pneumonia are discovered, and the cases occur secondarily worldwide along with the spread of epidemic situations. The new type coronavirus (2019-nCoV) is formally named as SARS-CoV-2 by the international committee for virus classification, and the resulting NCP is the B-type infectious disease in China and is brought into the management of the A-type infectious disease. The transmission way is a non-body fluid transmission way, and comprises transmission ways such as respiratory droplets, close contact, aerosol, digestive tract and the like, and the virus has strong infectivity and high serious risk.

The current epidemiological data suggest that the severity rate of the disease is about 2.7%, and most patients are light or common. At present, no effective antiviral drugs are used for treating the disease, and potential epidemic-resisting drugs based on SARS and MERS research results, such as Favipiravir, chloroquine phosphate, reideciclovir and the like, have no current clinical research data published. Therefore, the method has important significance for the research on the traditional Chinese medicine differentiation and treatment characteristics of the light or common type new coronary pneumonia. The curative effect evaluation data of the early traditional Chinese medicine for treating the new coronary pneumonia show that the traditional Chinese medicine has remarkable advantages for improving the symptoms of the patient and shortening the recovery time. The novel coronavirus pneumonia belongs to the categories of epidemic diseases and pestilence in the traditional Chinese medicine. The history of traditional Chinese medicine diagnosis and treatment of pestilence diseases is long-running, and the "saying" the spreading characteristics of epidemic diseases in epidemic patients and people "indicates that the epidemic diseases are also spreading. Su Wen heritage, st.P. treatise on Style of academy of flexure (cloud): "the five epidemic diseases are all easy to be infected, have no question about the size and have similar symptoms", wu Jutong "Wen Bing" (diagnosis of epidemic febrile diseases): epidemic disease sufferers who have severe epidemic qi and are often accompanied with foul turbidity, such as families who work and make things, all describe the infectivity and pathogenesis of epidemic diseases. Wu He can also be indicated in pestilence treatise: the disease is caused by cold, summer-heat and damp, and is caused by foreign qi in the world. The scope of 'six excesses' is broken through for the first time, the 'foreign qi' is clearly indicated as an important cause of the plague, meanwhile, the 'foreign qi' is also indicated as a disease, one qi becomes a disease, and the 'foreign qi' is emphasized to be different in types, different diseases are caused, and organ parts invaded by the 'foreign qi' are different.

The new type coronavirus (SARS-CoV-2) is structurally very similar to SARS-CoV and MERS-CoV, but the clinical syndromes and the onset characteristics of the diseases caused by them are different. The clinical characteristics of the novel coronavirus pneumonia and the research results of the traditional Chinese medicine syndromes are comprehensively analyzed, and the cold, heat, dampness and toxicity are main pathological factors of the early and middle stages of the pneumonia, wherein the dampness is the core of disease change, and the disease position is mainly in the lung and relates to the spleen and the stomach. The disease is developed in 2019 and at the end of the year, and scholars analyze the disease as damp-toxin disease according to the theory of five fortune and six qi. According to clinical symptoms, patients often have symptoms of weakness, tiredness, expectoration, chest distress, poor appetite, loose stool, greasy tongue coating and the like, and the symptoms are consistent with the syndrome of dampness pathogen. In winter, damp pathogen is easy to combine with cold, while pathogenic factors of epidemic toxin have fire-heat property, and patients have different constitutions, so it can have different cold-dampness and damp-heat, which is the same as syndrome differentiation and classification part of TCM, "pneumonia treatment scheme for novel coronavirus infection (trial sixth edition). The leaf-Tianshiyun' firstly attacks the lung due to the upper pathogenic heat, and patients with new coronary pneumonia often have respiratory symptoms such as cough, expectoration, chest distress, etc., so the pathological changes are in the lung. However, the spleen governs transportation and transformation of water-dampness, and dampness-toxicity invades externally and stays internally in the spleen, so that dampness-toxicity is difficult to remove and lingering and difficult to heal due to dysfunction of transportation and transformation.

Disclosure of Invention

The invention aims to: aiming at the problems in the prior art, the invention provides an epidemic prevention traditional Chinese medicine composition, a preparation method and pharmaceutical application thereof.

The technical scheme is as follows: the epidemic prevention traditional Chinese medicine composition comprises the following components in parts by weight: 5 to 15 parts of notopterygium root, 5 to 30 parts of perilla leaf, 3 to 20 parts of eupatorium, 5 to 12 parts of wrinkled gianthyssop herb, 3 to 15 parts of bran-fried rhizoma atractylodis, 3 to 15 parts of bupleurum, 3 to 12 parts of melilota japonica leaf, 5 to 30 parts of sweet wormwood herb, 2 to 12 parts of mint, 3 to 15 parts of burnt medicated leaven and 2 to 12 parts of liquorice.

Preferably, the epidemic prevention traditional Chinese medicine composition comprises the following components in parts by weight: 10 parts of notopterygium root, 10 parts of perilla leaf, 10 parts of eupatorium, 10 parts of wrinkled gianthyssop herb, 10 parts of bran-fried rhizoma atractylodis, 10 parts of radix bupleuri, 10 parts of loquat leaf, 10 parts of sweet wormwood herb, 6 parts of mint, 12 parts of charred medicated leaven and 3 parts of liquorice.

Further, the preparation method of the epidemic prevention traditional Chinese medicine composition comprises the following steps:

(1) Distilling herba Menthae, herba Artemisiae Annuae, folium Perillae and Notopterygii rhizoma with water, separating and collecting volatile oil, and collecting residue;

(2) Mixing the residue of step (1) with herba Eupatorii, herba Agastaches, rhizoma Atractylodis parched with bran, bupleuri radix, folium Eriobotryae Preparata, massa Medicata Fermentata preparata and Glycyrrhrizae radix, decocting in water, and concentrating the decoction to obtain fluid extract; adding ethanol, refrigerating for 12-24 hr, filtering to obtain water extraction and ethanol precipitation solution, recovering ethanol, and concentrating to obtain extract;

(3) Drying and crushing the extract obtained in the step (2), and adding auxiliary materials and the volatile oil obtained in the step (1) to prepare the preparation.

In the step (1), the water addition amount of the mint, the sweet wormwood herb, the perilla leaf and the notopterygium root is 8-12 times of the weight of each component, and the components are soaked for 0.5-1 hour and then distilled.

In the step (2), the decoction dregs and the decoction pieces are mixed and decocted for two times, the water adding amount is at least 5 times of the weight of the decoction pieces each time, the decoction is decocted for at least 0.5 hour each time, the decoction liquids in the two times are mixed, and the mixture is concentrated to clear paste with the relative density of 1.10-1.15. Wherein the eupatorium, the wrinkled gianthyssop herb, the rhizoma atractylodis stir-fried with bran, the radix bupleuri, the loquat leaf, the burnt medicated leaven and the liquorice are soaked in water for 0.5 hour in advance. Preferably, when the decoction is combined and decocted, the water adding amount of the two times is 8 times of the total decoction piece amount.

And (3) adding ethanol into the clear paste in the step (2) until the weight content of the ethanol is 60%, uniformly mixing, refrigerating for 12-24 hours, filtering to obtain water extraction and ethanol precipitation liquid, recovering the ethanol, and continuously concentrating to obtain an extract with the relative density of more than 1.30.

In the step (3), the extract is dried under reduced pressure and crushed into fine powder, corresponding auxiliary materials are added according to the requirements of dosage forms, and various oral dosage forms including granules, powder, tablets, capsules or pills are prepared by the conventional process; or directly diluting the extract with water, and making into oral liquid. Preferably, the preparation is granules, oral liquid or powder. Wherein, when preparing the granules, the obtained fine powder is mixed according to the proportion of 1: adding dextrin into the mixture according to the proportion of 1 to 3, uniformly mixing the mixture, preparing granules, drying and spraying the volatile oil separated in the step (1).

The application of the epidemic prevention traditional Chinese medicine composition in preparing the medicines for treating viral upper respiratory tract infection is also within the protection scope of the invention. The viral upper respiratory tract infection diseases comprise symptoms such as fever (abnormal body temperature), cough, nasal obstruction, rhinorrhea, nausea and the like.

The epidemic prevention traditional Chinese medicine composition is combined with an antiviral drug and is applied to preparation of a drug for treating viral upper respiratory tract infection. The antiviral drug is selected from: oseltamivir and the like.

The inventor considers that the syndrome of dampness-toxicity stagnated in the lung and the dysfunction of the spleen and the stomach are the main pathogenesis of the early and middle stage coronary pneumonia, establishes the dialectical treatment of the prescription, and creates the Qiang Huo dampness-eliminating and plague-clearing mixture aiming at the pathogenesis characteristics of the disease, so as to treat the syndrome of the early and middle stage dampness-toxicity stagnated in the lung and the dysfunction of the spleen and the stomach of the novel coronavirus pneumonia. In the formula, notopterygium root and rhizoma atractylodis are used as monarch drugs for promoting the circulation of qi and eliminating dampness; folium Perillae, herba Eupatorii, herba Agastaches, aromatic for removing filth, herba Artemisiae Annuae, bupleuri radix, and herba Menthae as ministerial drugs; loquat leaf and medicated leaven can ease qi of lung and spleen, and licorice root, radix Glycyrrhizae Praeparata can regulate the actions of the other drugs, acting as guiding drugs. The medicines are combined to play the role of eliminating dampness and clearing plague, and clinical tests prove that the traditional Chinese medicine has obvious curative effect.

The notopterygium root in the invention is derived from dried rhizome and root of notopterygium root or notopterygium root with wide leaves of Umbelliferae family. Has the effects of relieving exterior syndrome, dispelling cold, dispelling pathogenic wind, removing dampness, and relieving pain. Can be used for treating wind cold, headache, stiff neck, rheumatalgia, and soreness of shoulder and back. The main chemical components are active components such as coumarins, volatile oil and terpenes, sugar and glycosides, organic acid and phenols, polyacetylene, etc., wherein the volatile oil and terpenes, coumarins, organic acid and phenols in Notopterygii rhizoma are contained in large amount. Notopterygium root has various pharmacological activities, and modern researches show that the Notopterygium root has obvious activities of resisting inflammation, oxidation, arrhythmia, bacteria, cancer cell proliferation, fever, pain and the like.

The folium Perillae is derived from dried leaf (or twig) of Perilla frutescens (L.) Britt. Has the effects of relieving exterior syndrome, dispelling cold, promoting qi circulation, regulating stomach function, etc. Can be used for treating wind-cold type common cold, cough, emesis, vomiting of pregnancy, and fish and crab poisoning. The pharmacological action of the perilla leaves is mainly shown as follows: (1) antibacterial and antiviral (2) hemostatic effect: (1) tranquilizing and relieving pain; (3) antioxidation; (4) anti-tumor effect.

Eupatorium fortunei is derived from the dried aerial part of Eupatorium fortunei Turcz. Has the effects of aromatizing, eliminating dampness, activating spleen, stimulating appetite, relieving exterior syndrome, relieving summer heat and the like. Can be used for treating damp obstruction in middle energizer, gastric fullness, emesis, halitosis, sialism, summer-heat, damp exterior syndrome, fever, listlessness, and chest distress. The main chemical components in the eupatorium are volatile oil compounds, and the eupatorium has various pharmacological effects of resisting inflammation, dissolving phlegm, resisting tumors and the like.

Herba Agastaches is derived from dried aerial parts of herba Agastaches of Labiatae. Has the functions of eliminating turbid pathogen with aromatics, regulating the middle warmer, relieving vomiting, relieving exterior syndrome, relieving summer heat, etc. Can be used for treating damp obstruction in middle warmer, abdominal distention, emesis, summer-heat dampness exterior syndrome, early stage of damp-warm syndrome, fever, listlessness, chest distress, cold-dampness, summer-heat, abdominal pain, emesis, diarrhea, nasosinusitis, and headache. The agastache rugosus mainly contains volatile oil, flavonoid components, trace elements and other components, and the volatile oil is mostly a small molecular terpenoid compound, has strong fragrance and good pharmacological action. Modern researches show that the agastache rugosus has the effects of protecting gastrointestinal tract, resisting pathogenic microorganisms, resisting inflammation, relieving pain, relieving fever, stopping vomiting, relieving cough, reducing phlegm, relaxing the bowels, resisting oxidation, resisting tumors, regulating immune system and the like.

Atractylodes lancea is derived from dried rhizome of Atractylodes lancea Lancea (Thunb.) DC. Or Atractylodes chinensis Koidz. Has the effects of eliminating dampness, strengthening spleen, dispelling pathogenic wind, dispelling cold, improving eyesight, etc. Can be used for treating damp obstruction of middle energizer, abdominal distention, diarrhea, edema, and tinea pedis . Rheumatic arthralgia, wind-cold type common cold, night blindness, dim eyesight and eye dryness. The chemical components of rhizoma Atractylodis are mainly sesquiterpenes, eneynes, triterpenes, steroids, aromatic glycosides, etc. Modern researches prove that the rhizoma atractylodis has the effects of resisting inflammation, reducing blood sugar, resisting anoxia, resisting bacteria and viruses, protecting liver, regulating digestive system and nervous system, and the like.

The bupleuri radix is derived from dried root of Bupleurum scorzonerifolium DC or Bupleurum scorzonerifolium Willd. Has the effects of dispelling heat, relieving depression of the liver-qi, and lifting yang qi. Can be used for treating common cold, fever, alternating chills and fever, distending pain in chest and hypochondrium, menoxenia, uterine prolapse, and proctoptosis. Modern pharmacological studies prove that the bupleurum has the effects of relieving fever, calming, easing pain, resisting inflammation, resisting bacteria, enhancing immunity, resisting depression, resisting tumors and the like.

The folium Eriobotryae is derived from dried leaves of Lindl of Eriobotrya japonica (Eriobotrya japonica, rosaceae). Has the functions of clearing away lung heat, relieving cough, lowering adverse qi, stopping vomiting, etc. Can be used for treating cough due to lung heat, asthma, vomiting due to stomach heat, dysphoria with smothery sensation, and thirst. The loquat leaves mainly contain flavone and its glycoside compounds, triterpenic acid compounds, organic acid compounds, volatile oil compounds, inorganic elements and other compounds. Pharmacological research shows that the loquat leaves have pharmacological activities of resisting inflammation, eliminating phlegm, relieving cough, resisting pulmonary fibrosis, resisting oxidation, reducing blood sugar, resisting tumor, stopping vomit and the like.

The herba Artemisiae Annuae is derived from dried aerial parts of Artemisia annua L. Has the effects of clearing deficiency heat, removing bone-steaming, relieving summer-heat, preventing malaria, and eliminating jaundice. Can be used for treating yin impairment due to pathogenic warm, fever at night and early cold, fever due to yin deficiency, hectic fever due to yin deficiency, fever due to summer-heat pathogen, malaria fever due to cold, and jaundice due to damp-heat. The main chemical components are sesquiterpene, diterpenoid, flavonoid, phenylpropanoids, coumarins, volatile oil and the like. Modern researches show that the sweet wormwood herb extract and the monomeric compound thereof have pharmacological effects of antimalarial, anti-tumor, bacteriostasis, disinsection, antipyretic, anti-inflammatory, immunoregulation and the like.

The mint is derived from dried aerial parts of the mint plant Mentha haplocalyx Briq. Has the effects of dispelling wind and heat, clearing head and eyes, relieving sore throat, promoting eruption, soothing liver, promoting qi circulation and the like. Can be used for treating wind-heat type common cold, headache, conjunctival congestion, pharyngitis, aphtha, rubella, measles, and chest and hypochondrium swelling. The chemical components of the mint are mainly (1) mint oil; (2) Non-volatile components (1) phenol compounds (2) amino acids (3) trace elements, etc.; modern researches show that the peppermint oil has the effects of (1) cooling and relieving itching, (2) acting on a central nervous system, (3) promoting penetration, (4) resisting early pregnancy, resisting implantation, inhibiting uterine contraction, (5) resisting fungi and resisting viruses. The herba Menthae nonvolatile components have effects of protecting liver, promoting bile flow, resisting tumor, resisting oxidation, and blackening hair.

Medicated leaven is prepared by fermenting coarse powder of herba Polygoni Hydropiperis, herba Artemisiae Annuae, herba Xanthii, semen Phaseoli, and semen Armeniacae amarum, adding flour and testa Tritici. Has the effects of strengthening spleen and stomach, promoting digestion and regulating middle warmer. Can be used for treating food stagnation, chest distress, abdominal distention, emesis, dysentery, and infantile abdominal mass. Contains digestive enzyme, vitamin B complex, ergosterol, volatile oil, flavonoid and glycoside. Modern researches show that the compound has various pharmacological activities of enhancing gastrointestinal motility, promoting gastric acid secretion, improving intestinal flora disorder, promoting intestinal movement and the like.

Glycyrrhiza uralensis Fisch. Glycyrrhiza inflata Bat. Or Glycyrrhiza glabra L. Is derived from dried root and rhizome of Glycyrrhiza uralensis Fisch. Or Glycyrrhiza glabra L. Of Leguminosae. Has the effects of invigorating spleen and replenishing qi, clearing away heat and toxic materials, eliminating phlegm and relieving cough, relieving spasm and pain, and harmonizing the medicines. Can be used for treating weakness of the spleen and the stomach, lassitude and hypodynamia, palpitation and shortness of breath, cough and excessive phlegm, abdominal and limb spasm and pain, carbuncle and sore, and relieving toxicity and intensity of the medicine. The main chemical components of the liquorice are glycyrrhetinic acid, glycyrrhiza polysaccharide, licoflavone, glycyrrhizic acid, licochalcone A, glycyrrhizin and the like. Modern researches believe that pharmacological actions of glycyrrhetinic acid have anti-inflammatory, adrenocortical hormone-like effects, effects on myocardial ischemia, anticancer and antitumor effects; licoflavone has effects of resisting tumor, scavenging free radicals, and resisting aging; the glycyrrhiza polysaccharide has antibacterial, immunity regulating, antiviral, and osteoarthritis preventing and treating effects; glycyrrhizic acid has anti-fibrosis and immunoregulatory effects; licochalcone A has antiinflammatory, antimalarial, antiparasitic, and antibacterial effects; glycyrrhizin has antiallergic, antitumor, antiinflammatory, and immunoregulatory effects.

Has the advantages that: compared with the prior art, the invention aims at the pathogenesis characteristics of viral upper respiratory tract infection diseases such as stagnation of damp toxin in the lung and dysfunction of the spleen and stomach, and establishes the dialectical treatment of the formula; the preparation process of the traditional Chinese medicine compound is reasonable in design, green and environment-friendly, can be prepared into various dosage forms, and is convenient to use. The composition has remarkable curative effect and wide market application prospect as determined by clinical tests.

Detailed Description

The present application will be described in detail with reference to specific examples.

Example 1

An epidemic prevention traditional Chinese medicine composition comprises the following components in parts by weight: 10 parts of notopterygium root, 10 parts of perilla leaf, 10 parts of eupatorium, 10 parts of wrinkled gianthyssop herb, 10 parts of bran-fried rhizoma atractylodis, 10 parts of radix bupleuri, 10 parts of loquat leaf, 10 parts of sweet wormwood herb, 6 parts of mint, 12 parts of charred medicated leaven and 3 parts of liquorice.

The preparation method comprises the following steps:

extracting herba Menthae, herba Artemisiae Annuae, folium Perillae and Notopterygii rhizoma with 10 times of water until volatile liquid is completely extracted, separating and collecting volatile oil, mixing the residue and liquid medicine with other decoction pieces in the formula, adding water to 8 times of total decoction pieces, soaking for 0.5 hr, decocting for 30min, and filtering; adding 8 times of water for the second time, decocting for 30 minutes, filtering, mixing the two filtrates, concentrating under reduced pressure to relative density of 1.15, adding ethanol to 60%, mixing, refrigerating for 24 hours, filtering to obtain supernatant, recovering ethanol under reduced pressure, concentrating to relative density of 1.30, drying under reduced pressure, pulverizing into fine powder, adding adjuvants, granulating, drying, adding volatile oil, mixing, and making into granule.

Example 2

9 parts of notopterygium root, 15 parts of perilla leaf, 10 parts of eupatorium, 9 parts of wrinkled gianthyssop herb, 10 parts of rhizoma atractylodis stir-baked with bran, 10 parts of radix bupleuri, 10 parts of loquat leaf, 15 parts of sweet wormwood herb, 5 parts of mint, 12 parts of medicated leaven and 2 parts of liquorice, and the preparation method is the same as that of example 1 to prepare granules.

Example 3

6 parts of notopterygium root, 15 parts of perilla leaf, 10 parts of fortune eupatorium herb, 12 parts of wrinkled gianthyssop herb, 9 parts of bran-fried rhizoma atractylodis, 6 parts of Chinese thorowax root, 12 parts of honey loquat leaf, 15 parts of sweet wormwood herb, 6 parts of mint, 9 parts of charred medicated leaven and 4 parts of liquorice, and the preparation method is the same as that of the example 1 to prepare the granules.

Example 4

6 parts of notopterygium root, 15 parts of perilla leaf, 10 parts of fortune eupatorium herb, 12 parts of wrinkled gianthyssop herb, 9 parts of rhizoma atractylodis fried with bran, 6 parts of radix bupleuri, 12 parts of loquat leaf, 15 parts of sweet wormwood herb, 6 parts of mint, 9 parts of medicated leaven and 4 parts of liquorice, the preparation method is the same as the embodiment 1, the extractum is extracted and prepared, water is added for dilution, the volatile oil is added, the mixture is evenly mixed, the single dose is subpackaged, and the sterilization is carried out, thus obtaining the oral liquid.

Example 5

6 parts of notopterygium root, 15 parts of perilla leaf, 10 parts of fortune eupatorium herb, 12 parts of wrinkled gianthyssop herb, 9 parts of rhizoma atractylodis fried with bran, 6 parts of Chinese thorowax root, 12 parts of loquat leaf, 15 parts of sweet wormwood herb, 6 parts of mint, 9 parts of medicated leaven and 4 parts of liquorice, and the preparation method is the same as that of example 4, and the mixture is obtained by multi-dose subpackaging and sterilization.

Clinical trial

Control group (oseltamivir group):

in 106 patients diagnosed with viral infection, oseltamivir was administered for treatment, and 56 men and 50 women were orally administered for 3 days, and then observed to see whether the body temperature decreased or the symptoms improved.

As a result: after 3 days of treatment, 74 patients return to normal body temperature, and the symptoms (cough, nasal obstruction, watery nasal discharge and nausea) are obviously improved. 17 cases of no improvement and 15 cases of falling-off, and the total effective rate is 70.0 percent.

Observation group (traditional Chinese medicine + oseltamivir group of the present application):

103 patients diagnosed with exogenous febrile disease are selected, the decoction of the formula in the example 1 is combined with western medicines (oseltamivir, the usage amount is the same as that of the western medicines) to carry out clinical treatment observation, wherein 52 men and 51 women take the decoction orally for 3 days, and then whether the body temperature is normal or whether symptoms (cough, nasal obstruction, watery nasal discharge and nausea) are improved or not is observed.

As a result: after 3 days of treatment, 85 patients return to normal body temperature, and symptoms (cough, nasal obstruction, watery nasal discharge and nausea) are obviously improved. There were no 18 cases of improvement (including 10 cases of exfoliation) and the total effective rate was 82.5%, as detailed in the following table.

	N	Is effective	Invalidation	Effective rate%
					Treatment group A	31	24	7	77.4
Treatment group B	40	35	5	87.5
					Treatment group C	32	26	6	81.3
Total number of	103	85	18	82.5

SPSS17 is used for carrying out chi-square test on effective rates of a control group (oseltamivir group) and an observation group (traditional Chinese medicine + oseltamivir group), statistical results show that the effective rate of the control group is 70.0%, the effective rate of the observation group is 82.5%, and the effective rates between the two groups have statistical difference (P < 0.05), which prompts that the traditional Chinese medicine and the oseltamivir can better improve uncomfortable symptoms such as fever caused by virus infection compared with the oseltamivir alone, and the detailed results are shown in the following table.

	N	Is effective	Invalidation	Falling off	High efficiency
						Control group	106	74	17	15	70.0％
Observation group	103	85	8	10	82.5％

The cases are as follows:

patient 1 woman 53 years old

Patients had no clear epidemiological history. Fever appears in 29 days after 1 month, the highest is 39.2 degrees, aversion to cold, dry cough, little white phlegm, slight chest distress, no asthma, muscle soreness and hypodynamia occur, and after the clinic of fever clinic of our hospital, the routine of emergency blood survey is as follows: white blood cell count 6.96 x 10 ⁹ L, percentage of neutrophils 77.6%, percentage of lymphocytes 13.5%, hypersensitive C-reactive protein 2.59mg/L, thoracic HRCT: two lower pulmonary fibrosis with infection of the left lower lung, two lungs with multiple nodules, partly considered as inflammatory nodules, were treated with oseltamivir, and the body temperature decreased earlier, with fever remaining. 2 months and 1 day patients go to the clinic to review the blood routine: white blood cell count 4.42 x 10 ⁹ L, fine neutral particlesAbsolute value of cell 2.99 x 10 ⁹ L, lymphocyte absolute value 1.06 x 10 ⁹ L, hypersensitive C reactive protein 14.95mg/L; chest HRCT: inflammation of the lower lobes of the two lungs; the right inferior lobe of the lung, bullous alveolus; two lungs have multiple nodules. And (5) reserving isolation.

After the mixture is left for observation, oseltamivir is added; in example 1, the prescription of the composition is 3 doses, and one dose is taken every day.

The body temperature is normal the next day, cough is better than before, sputum is little and white, chest distress is slight, muscle soreness is relieved, and hypodynamia is the same as before. The expert group consults CAP and switches to the general ward to continue the treatment.

Patient 2 female 53 years old

The patient is Nanjing home nurse, 1 month 17 days of Guangchan in Sichuan takes the train menses stopping Wuhan, 1 month 28 days of Guining takes the train menses stopping Wuhan, the patient has a dinner with the person in the period, 1 month 28 days of Guining is automatically isolated in a hotel for 10 days, and the patient goes out to a supermarket for shopping in the period and wears a mask. Return to employer on day 2, month 7, and cough began to appear. Intermittent expectoration, cough with little yellow purulent sputum, sticky texture, dry mouth, bitter taste, dry throat and itching throat, and no obvious improvement after self-administration. The patient arrives at the fever clinic of the hospital after 11 days 2 months, and the blood is checked urgently: white cell count 7.60 x 10 ⁹ L, neutrophil absolute value 5.59 x 10 ⁹ L, absolute lymphocyte value 1.02 x 10 ⁹ /L, hypersensitive C reactive protein<0.50mg/l; liver and kidney function: 90U/L of glutamic-oxaloacetic transaminase, 94U/L of glutamic-pyruvic transaminase and 98U/L of gamma-glutamyl transpeptidase; chest CT: poor ventilation and perfusion of both lungs; the lingual segment and the inferior lobe of the left lung are slightly inflamed, and the superior lobe of the two lungs has a plurality of small nodules, considering that fibrous nodules may be large. And then isolated for observation.

The patient in the next day has better cough, little white phlegm, easy cough, dry mouth, bitter taste and better throat and itching throat. The novel coronary pharyngeal swab was negative in nucleic acid examination at 2 months and 13 days, and isolation was released.

Patient 3 female 33 years old viral pneumonia

The patient drives to Hunan once in 17 days 1 month, passes through Hubei Chongyang high speed, stays for about 30min in a service area on the way, and returns to peace after driving in 26 days without staying on the way. Its daughter is in about 1 month and 26 daysThere has been a fever with cough. Patients with pharynx itch and cough and dry cough mainly appear in 2 months and 8 days, the patients are intolerant to cold and have fever, the blood-checking routine of the hospitals in east mountain community in Jiangning area is normal (not reported), and the patients do not get better after taking Pudilan oral liquid and Suhuang cough-relieving capsules orally for 4 days. Visit from 2 months and 14 days to the department of respiratory disease of our hospital, blood routine: white blood cell count 7.68 x 10 ⁹ L, neutrophil absolute 4.35 x 10 ⁹ L, absolute lymphocyte value 2.74 x 10 ⁹ L, hypersensitive C-reactive protein<0.50mg/l; flat scanning of chest high-resolution CT: inflammation of the upper lobes of the left lung. The patient was considered to have a history of foreign travel and was kept in isolation.

After the mixture is left for observation, oseltamivir is added; the decoction of the prescription in the example 1 is 3 doses, and one dose is taken every day.

The patient has no fever the next day, the body temperature is measured to be 36.5 ℃, the patient has occasional cough, the novel nucleic acid coronavirus is negative in sampling, and the isolation is released.

The patient with definite diagnosis of new coronary disease is treated according to the requirement of the test in the isolation period of the hospital, and if the patient is transferred to a fixed-point hospital after taking the medicine for three days, the patient does not take the traditional Chinese medicine any more. And (4) excluding the new crown, if the medicine taking is invalid for three days, continuing to take the medicine, and carrying out follow-up on the telephone.

Claims

1. A traditional Chinese medicine composition for improving viral upper respiratory tract infection symptoms or viral pneumonia symptoms is characterized by comprising the following components in parts by weight: 5 to 15 parts of notopterygium root, 5 to 30 parts of perilla leaf, 3 to 20 parts of eupatorium, 5 to 12 parts of wrinkled gianthyssop herb, 3 to 15 parts of bran-fried rhizoma atractylodis, 3 to 15 parts of bupleurum, 3 to 12 parts of melilota japonica leaf, 5 to 30 parts of sweet wormwood herb, 2 to 12 parts of mint, 3 to 15 parts of burnt medicated leaven and 2 to 12 parts of liquorice.

2. The traditional Chinese medicine composition for improving viral upper respiratory infection symptoms or viral pneumonia symptoms according to claim 1, characterized in that the traditional Chinese medicine composition is composed of the following components in parts by weight: 10 parts of notopterygium root, 10 parts of perilla leaf, 10 parts of eupatorium, 10 parts of wrinkled gianthyssop herb, 10 parts of bran-fried rhizoma atractylodis, 10 parts of radix bupleuri, 10 parts of loquat leaf, 10 parts of sweet wormwood herb, 6 parts of mint, 12 parts of charred medicated leaven and 3 parts of liquorice.

3. The traditional Chinese medicine composition for improving viral upper respiratory infection symptoms or viral pneumonia symptoms according to claim 1, characterized in that the traditional Chinese medicine composition is composed of the following components in parts by weight: 9 parts of notopterygium root, 15 parts of perilla leaf, 10 parts of fortune eupatorium herb, 9 parts of wrinkled gianthyssop herb, 10 parts of bran-fried rhizoma atractylodis, 10 parts of Chinese thorowax root, 10 parts of honey loquat leaf, 15 parts of sweet wormwood herb, 5 parts of mint, 12 parts of charred medicated leaven and 2 parts of liquorice.

4. The traditional Chinese medicine composition for improving viral upper respiratory infection symptoms or viral pneumonia symptoms according to claim 1, characterized in that the traditional Chinese medicine composition consists of the following components in parts by weight: 6 parts of notopterygium root, 15 parts of perilla leaf, 10 parts of fortune eupatorium herb, 12 parts of wrinkled gianthyssop herb, 9 parts of bran-fried rhizoma atractylodis, 6 parts of Chinese thorowax root, 12 parts of honey loquat leaf, 15 parts of sweet wormwood herb, 6 parts of mint, 9 parts of charred medicated leaven and 4 parts of liquorice.

5. A Chinese medicinal preparation, characterized in that it is prepared from the Chinese medicinal composition of any one of claims 1-4.

6. The Chinese medicinal preparation according to claim 5, wherein the Chinese medicinal preparation is granules, powder, tablets, capsules, pills, oral liquid or mixture.

7. The Chinese medicinal preparation according to claim 6, wherein the Chinese medicinal preparation is a granule, an oral liquid or a mixture.

8. The traditional Chinese medicine preparation according to claim 5, which is prepared by the following method:

(3) Drying and crushing the extract obtained in the step (2), and adding auxiliary materials and the volatile oil obtained in the step (1) to prepare the traditional Chinese medicine preparation.

9. The traditional Chinese medicine preparation according to claim 6 or 7, which is an oral liquid or a mixture, and is prepared by the following method:

(3) Diluting the extract obtained in the step (2) with water, adding the volatile oil, mixing uniformly, subpackaging with single dose and sterilizing to prepare oral liquid or subpackaging with multiple doses and sterilizing to prepare a mixture.

10. The traditional Chinese medicine preparation according to claim 8, wherein in the step (1), the water added into the mint, the sweet wormwood herb, the perilla leaf and the notopterygium root is 8-12 times of the weight of each component, and the mint, the sweet wormwood herb, the perilla leaf and the notopterygium root are soaked for 0.5-1 hour and then distilled.

11. The Chinese materia medica preparation according to claim 8, wherein in the step (2), the dregs of a decoction are combined with the eupatorium, the wrinkled gianthyssop herb, the bran-fried rhizoma atractylodis, the radix bupleuri, the melilota japonica leaves, the charred medicated leaven and the liquorice in the formula amount, and are decocted for two times, the water adding amount is at least 5 times of the total weight of the eupatorium, the wrinkled gianthyssop herb, the bran-fried rhizoma atractylodis, the radix bupleuri, the melilota japonica leaves, the charred medicated leaven and the liquorice, the decoction is decocted for at least 0.5 hour each time, and the two decoctions are combined and concentrated into clear paste with the relative density of 1.10-1.15.

12. The Chinese medicinal preparation of claim 8, wherein the eupatorium, agastache rugosus, rhizoma atractylodis macrocephalae preparata with bran, radix bupleuri, eriobotrya japonica leaves, medicated leaven preparata and radix glycyrrhizae are soaked in water for 0.5 hour in advance.

13. The traditional Chinese medicine preparation as claimed in claim 8, wherein in step (2), ethanol is added into the clear paste to make the weight content of ethanol be 60%, the mixture is mixed evenly, refrigerated for 12-24 hours, filtered to obtain water extraction and ethanol precipitation solution, the ethanol is recovered, and the mixture is continuously concentrated to obtain extract with the relative density of more than 1.30.

14. Use of the Chinese medicinal composition of any one of claims 1-4 in the preparation of a medicament for treating viral upper respiratory infection or viral pneumonia.

15. Use of a Chinese medicinal composition as claimed in any one of claims 1-4 in combination with an antiviral agent in the manufacture of a medicament for the treatment of viral upper respiratory infection or viral pneumonia.