Traditional Chinese medicine composition, preparation method thereof and application of traditional Chinese medicine composition in preparation of medicine for treating upper respiratory infection

Through a traditional Chinese medicine composition that includes low -ground tea, stiff silkworm, Chenpi, ginger Pinellia, Beisha ginseng, and licorice, the problem of resistance to drug resistance and poor Chinese medicine treatment during antibiotic therapy in infection in the treatment of antibiotics has achieved significant effects. The effects of antitussive, phlegm, anti -inflammatory and detoxifying and pain relief effects have curative effect on the new crown and myocardial injury.

CN119345287APending Publication Date: 2025-01-24SHANGHAI RUISHENG HEALTH TECHNOLOGY GROUP CO LTD +1
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Patent Information

Application Number
CN202411566656.X
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2024-11-05
Publication Date
2025-01-24

AI Technical Summary

Technical Problem

In the prior art, in the treatment of upper respiratory tract infections, the long-term use of antibiotics can easily lead to drug resistance, and the traditional Chinese medicine treatment lacks systematic and thoroughness, and its efficacy is not obvious.

Method used

Provided is a traditional Chinese medicine composition, including Aidi tea, fried silkworm, dried tangerine peel, ginger pinellia, Adenophora miltiorrhiza and licorice. Volatile oil and aqueous solution are extracted through steam distillation, combined with β-cyclodextrin inclusion complex, and prepared into granules. Available in the form of tablets and hard capsules, it is used to treat upper respiratory tract infections.

Benefits of technology

The Chinese medicine composition has significant effects of antitussive, phlegm, anti -inflammatory, and detoxifying pain, and can effectively alleviate the symptoms of upper respiratory tract infections, such as dizziness, runny nose, itching, cough, sputum, chest tightness and asthma, and to the new crown, and to the new crown It has a significant effect with myocardial injury.

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Abstract

The invention discloses a traditional Chinese medicine composition as well as a preparation method and application thereof in preparation of a medicine for treating upper respiratory tract infection. The composition is prepared from the following raw material components in parts by weight: 25-35 parts of herba ardisiae japonicae, 12-20 parts of fried stiff silkworm, 10-15 parts of pericarpium citri reticulatae, 12-20 parts of ginger processed pinellia, 18-23 parts of radix glehniae and 12-20 parts of liquorice. The pharmaceutical composition can tonify qi and blood and strengthen breath; phlegm and saliva are removed, and the pains are smooth; the traditional Chinese medicine is mainly used for dispersing qi. The traditional Chinese medicine composition has obvious treatment effects on dizziness, rhinorrhea, throat itching, pharyngalgia, cough, expectoration, chest distress, asthma or new crowns and the like caused by upper respiratory tract infection.
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Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition and a preparation method thereof and application of the composition in preparing medicines for treating upper respiratory tract infections. Background Art

[0002] Upper respiratory tract infection (URTI, hereinafter referred to as "URTI") is a general term for acute inflammation of the nasal cavity, larynx or pharynx, mostly caused by viral infection. In severe cases, it can lead to pneumonia and myocardial damage. It is a common respiratory disease in clinical practice. In traditional Chinese medicine, it is called "cold, typhoid fever, cold, exogenous fever", etc., which belongs to the category of "physical weakness infection" and "chronic cough". The root cause of the disease is the weakness of internal organs caused by congenital deficiency or acquired diseases, and the lack of blood and qi in the lungs, spleen and kidneys, which leads to weak resistance to external evil. Syndrome differentiation includes wind-cold cold syndrome, wind-heat cold syndrome, summer heat cold syndrome, epidemic cold, etc.

[0003] Clinical western medicine treatment of upper respiratory tract infection mostly adopts antibiotics, which can effectively control the progression of the disease and assist symptomatic treatment drugs. The treatment of upper respiratory tract infection is effective, but the use of antibiotics, especially long-term use of antibiotics, can form drug resistance and produce toxic and side effects. Although there are Chinese medicines to treat upper respiratory tract infection, the dialectical treatment of Chinese medicine is not thorough and the effect is not obvious. Summary of the invention

[0004] The purpose of the present invention is to overcome the above-mentioned shortcomings and provide a Chinese medicine composition for treating upper respiratory tract infection.

[0005] Another object of the present invention is to provide a method for preparing the above-mentioned Chinese medicine combination.

[0006] Another object of the present invention is to provide the use of the above-mentioned Chinese medicine composition in the preparation of medicines for treating upper respiratory tract infections.

[0007] The object of the present invention is achieved in the following ways:

[0008] A Chinese medicine composition for treating upper respiratory tract infection, the composition is prepared from the following components in parts by weight:

[0009] 25-35 parts of dwarf tea, 12-20 parts of stir-fried silkworm, 10-15 parts of tangerine peel, 12-20 parts of ginger pinellia, 18-23 parts of northern adenophora, and 12-20 parts of liquorice.

[0010] Preferably, the above-mentioned Chinese medicine composition for treating upper respiratory tract infection is made of the following components in parts by weight:

[0011] 20 parts of Northern Adenophora, 15 parts of stir-fried Bombyx Batryticatus, 12 parts of dried tangerine peel, 15 parts of ginger pinellia, 30 parts of dwarf tea, and 15 parts of liquorice.

[0012] Dwarf tea is the dried whole herb of Ardisia japonica (Thunb.) Blume, a plant of the Myrsinaceae family. It is pungent, slightly bitter, and neutral in nature. It enters the lung and liver meridians. Bombyx mori Linnaeus is the dried body of the 4th to 5th instar larvae of the silkworm, an insect of the Bombyx mori Linnaeus family, infected (or artificially inoculated) with Beauveria bassiana (Bals.) Vuillant and killed. It is salty, pungent, and neutral in nature. It enters the liver, lung, and stomach meridians. Tangerine peel is the dried mature peel of Citrus reticulata Blanco, a plant of the Rutaceae family, and its cultivated varieties. It is pungent, bitter, and warm in nature. It enters the spleen meridians. Ginger Pinellia is one of the processed products of the dried tubers of Pinellia ternata (Thunb.) Breit., a plant of the Araceae family. It is pungent, warm in nature. It is toxic. It enters the spleen, stomach, and lung meridians. Adenophora littoralis is the dried root of Glehnia littoralis Fr.Schmidt ex Miq., a plant of the Umbelliferae family. It is sweet, slightly bitter, and slightly cold in nature. It enters the lung and stomach meridians. Licorice is the dried root and rhizome of Glycyrrhiza uralensis Fisch., a plant of the Leguminosae family. It is sweet and neutral in nature. It enters the heart, lung, spleen, and stomach meridians.

[0013] Preferably, the pharmaceutical composition of the present invention is prepared into a preparation with pharmaceutically acceptable excipients.

[0014] The preparation is preferably a granule, a tablet, a hard capsule, a soft capsule, a pill, a tea bag, or an acupuncture point patch.

[0015] The preparation method of the above-mentioned Chinese medicine composition is as follows:

[0016] The above six ingredients can be directly mixed and crushed for use;

[0017] Or you can directly boil the six herbs in water for use;

[0018] The following extraction steps are optimally used:

[0019] (1) taking Camellia sinensis and dried orange peel, crushing them into particles, extracting volatile oil by steam distillation, and obtaining volatile oil, medicinal residue and aqueous solution respectively;

[0020] (2) boiling the four ingredients of fried silkworm, ginger pinellia, northern adenophora and liquorice with the residues of the above-mentioned dwarf safflower and tangerine peel after extracting volatile oil twice, combining the two decoctions, standing, filtering, combining the aqueous solutions of the dwarf safflower and tangerine peel after extracting volatile oil, concentrating under reduced pressure to obtain an extract, vacuum drying to obtain a dry paste, and pulverizing into fine powder;

[0021] (3) mixing volatile oil and β-cyclodextrin in a weight ratio of 1:10-15 g / g to prepare an inclusion compound;

[0022] (4) Mixing the fine powder from step (2) and the inclusion compound from step (3).

[0023] Preferably, the conditions for extracting the volatile oil by steam distillation in step (1) are to add 6-8 times the weight of the medicinal material and heat to keep it slightly boiling for 5-6 hours.

[0024] Preferably, the decoction conditions in step (2) are as follows: adding 6-8 times the amount of water for the first time and decoct for 1-1.5 hours, and adding 5-7 times the amount of water for the second time and decoct for 1-1.5 hours.

[0025] Preferably, in step (3), β-cyclodextrin is ground with water and poured into a colloid mill. The colloid mill is started and a volatile oil dissolved in an appropriate amount of anhydrous ethanol is slowly and continuously added dropwise. After grinding, the mixture is vacuum dried at 40-60° C. to obtain an inclusion compound.

[0026] Preferably, in step (2), the extract is concentrated under reduced pressure to a relative density of 1.25 to 1.30 at 60°C, and the extract is concentrated under reduced pressure to a relative density of 1.25 to 1.30 at 60°C.

[0027] The obtained dry paste was crushed into fine powder.

[0028] Preferably, the powder is crushed into 30 mesh particles in step (1).

[0029] The Chinese medicine composition can be used in preparing medicines for treating upper respiratory tract infections.

[0030] It can also be used in the preparation of drugs for treating COVID-19 or myocardial damage.

[0031] For upper respiratory tract infection, Chinese medicine calls it "cold, typhoid fever, cold, exogenous fever", etc., which belong to the categories of "physical weakness infection" and "chronic cough". Congenital deficiency or acquired diseases cause the weakness of internal organs, and the lack of blood and qi in the lungs, spleen and kidneys, which leads to weak resistance to external evils, which is the root cause of the disease. Wind evil and summer heat, dampness, cold and heat evil enter through the mouth, nose and skin, invade the evil defense surface, stagnate in the skin, and the yin and yang fight, causing the lung qi to be out of balance, which is divided into wind heat, wind cold, summer dampness, qi deficiency, and both exterior and interior heat. Some people also believe that the initial stage of infection is mainly caused by evil, which belongs to the external infection of physical weakness; the evil poison gradually clears during the protracted period, and the virtual image is revealed; the recovery period is mainly to strengthen the body and clear the residual evil. In the protracted period or recovery period, the condition will be slow and severe, the symptoms are mixed, and the symptoms are constantly coming and going, resulting in cold and heat, disharmony between Ying and Wei, mixed deficiency and excess, and both exterior and interior diseases. This is the failure of Shaoyang pivot. The location of the infection is in the lungs, which control the qi of the whole body. When the external pathogen enters the lungs, the body is weak and the pathogen is lingering, resulting in symptoms such as nasal congestion, sneezing, runny nose, night sweats, chills and fever, general fatigue, muscle aches, etc. The lungs and large intestine are exterior and interior to each other. If the intestines are weak, the spleen and stomach are not in harmony, and the spleen fails to transport and transform, the lungs' function of protecting the body from external pathogens is damaged, which can easily lead to repeated infections.

[0032] The inventor believes that the lung controls the qi and controls breathing: to convert oxygen into carbon dioxide, the exchange plays a decisive role in this process. There are two cell membranes and connective tissues between the alveoli and the blood; after the connective tissue becomes fibrotic, its elasticity will be affected, resulting in the obstruction of carbon dioxide discharge and the formation of respiratory acidosis or acidosis; the treatment of fibrosis requires monounsaturated fatty acids. Why should we strengthen the body in clinical practice, and it should be ranked first, because once the lung forms phlegm, it needs the ability to discharge it. The lung controls the release and descending to regulate the whole body's qi: once the respiratory tract is blocked by phlegm, the qi will be disordered, the symptoms will develop quickly, and even suffocation and death will occur; therefore, the phlegm must be removed quickly, and most of the phlegm here refers to tangible phlegm; suctioning phlegm can be used for emergency but not for a long time. Only when the qi is unblocked can the water channel be regulated to balance the body's body fluids and avoid the formation of phlegm again. The lung faces all meridians and treats the joints: the main joints should dredge the qi and restore the functions of the internal organs, and the method of opening the orifices is the top priority.

[0033] In the Chinese medicine composition of the present invention, the dwarf tea is pungent and slightly bitter, has a neutral nature, belongs to the lung and liver meridian, has strong antitussive and expectorant power, and has the function of relieving asthma and removing blood stasis; the fried silkworm is salty, has a neutral nature, belongs to the liver meridian, and is good at resolving phlegm and dispersing knots, relieving spasms and relieving pain, and is a key medicine for throat paralysis; the two medicines work synergistically to relieve sore throat, itchy throat, fever and cough as the main medicine. Tangerine peel is bitter and pungent, has a warm nature, belongs to the lung and spleen meridian, and descends the qi to relieve cough, regulates dampness and wakes up the spleen to remove phlegm; Pinellia tuber is pungent and warm in nature, belongs to the lung, spleen and stomach meridian, has the function of resolving phlegm and dispersing knots, drying dampness and eliminating lumps; the two medicines work synergistically to relieve cough and sputum as the minister medicine. Northern Adenophora Root is sweet and slightly bitter, has a slightly cold nature, belongs to the lung and stomach meridian, is good at clearing lung heat and benefiting stomach fluid, on the one hand, assists fried silkworm and tea to relieve throat and relieve pain; on the other hand, it assists Pinellia tuber and tangerine peel to warm and dry the yin and damage the yin as an adjuvant. Licorice is sweet in taste and neutral in nature. It enters the heart, lung, spleen and stomach meridians. It is good at detoxifying, relieving pain, and harmonizing various medicines. It not only enhances the sore throat and analgesic effect of fried silkworm pupa, but also relieves the warming and dry nature of pinellia, and helps tangerine peel to soothe the stomach as a guiding drug.

[0034] Therefore, the pharmaceutical composition of the present invention can replenish qi and blood, strengthen breathing, remove phlegm and saliva, and clear the channels; treat joints and relieve qi. It has obvious relief and therapeutic effects on dizziness, runny nose, itchy throat, sore throat, cough and sputum, chest tightness and asthma caused by upper respiratory tract infection. It is particularly suitable for treating upper respiratory tract infection, and also has obvious therapeutic effects on treating new coronary or myocardial damage.

[0035] The present invention has also verified this through drug efficacy and clinical experiments:

[0036] (1) The Chinese medicine composition of the present invention has a significant antitussive effect by counting the number of coughs of mice per unit time.

[0037] (2) The effect of the Chinese medicine composition on the phenol red secretion in the mouse trachea was tested to prove that the Chinese medicine composition of the present invention has a significant expectorant effect.

[0038] (3) The experimental results of xylene-induced mouse ear swelling inflammation model showed that the Chinese medicine composition of the present invention has a significant anti-inflammatory effect.

[0039] (4) Clinical experiments have shown that the composition of the present invention has obvious therapeutic effects on dizziness, runny nose, itchy throat, sore throat, cough and sputum, chest tightness, asthma or COVID-19.

[0040] Therefore, the main innovations of the present invention are: 1. It is to organically combine the dialectical treatment of traditional Chinese medicine with the disease differentiation and treatment of modern medicine. The complex dialectical process of traditional Chinese medicine is simplified, and the pathological characteristics of the lung as a phlegm storage organ are organically combined based on the physiological functions of the lung that controls qi and controls breathing in traditional Chinese medicine; it is based on treating phlegm first when treating the lung and using pinellia and dwarf tea as the basis for formulating prescriptions. 2. It is also to dialectically unify the pathogenesis theory of traditional Chinese medicine and the physiological functions of viscera. Traditional Chinese medicine emphasizes cold, heat, deficiency, excess, wind, phlegm and blood stasis in treating the lung, while pinellia is mainly warm, and dwarf tea with the functions of clearing heat, removing dampness, promoting blood circulation and removing blood stasis is used as an adjuvant, so that the whole prescription has no risk of cold and heat bias; at the same time, it has a wider clinical use basis. 3. It is also to simplify the complex pathological process of the lung, based on the formulating idea of ​​treating phlegm, using dwarf tea with the function of relieving cough and asthma, and using fried silkworm pupa that relieves spasms and dispels wind to strengthen the expectorant and cough relieving effects. According to traditional Chinese medicine theory, long-term cough is caused by weakness, so it is combined with Radix Adenophorae which can nourish yin and clear the lungs. Its sweet and cold nature can assist in restraining the warming and drying effect of Pinellia ternata. The combination of these medicines can achieve significant clinical results. BRIEF DESCRIPTION OF THE DRAWINGS

[0041] Figure 1 This graph shows the effect of the test drug on the latency period of ammonia-induced cough in mice.

[0042] In the figure, compared with the model group, *P<0.05, **P<0.01, ***P<0.001; compared with the test drug J group, #P<0.05, ##P<0.01, ###P<0.001; compared with the test drug A group, $P<0.05, $$P<0.01, $$$P<0.001

[0043] Figure 2 This graph shows the effect of the test drug on the number of coughs induced by ammonia in mice.

[0044] In the figure, compared with the model group, *P<0.05, **P<0.01, ***P<0.001; compared with the test drug J group, #P<0.05, ##P<0.01, ###P<0.001; compared with the test drug A group, $P<0.05, $$P<0.01, $$$P<0.001

[0045] Figure 3 The effect of the tested drugs on the secretion of phenol red in the mouse trachea

[0046] In the figure, compared with the control group, *P<0.05, **P<0.01, ***P<0.001; compared with the test drug J group, #P<0.05, ##P<0.01, ###P<0.001; compared with the test drug A group, $P<0.05, $$P<0.01, $$$P<0.001

[0047] Figure 4 This graph shows the effect of the test drugs on xylene-induced ear swelling in mice.

[0048] In the figure, compared with the model group, *P<0.05, **P<0.01, ***P<0.001; compared with the test drug J group, #P<0.05, ##P<0.01, ###P<0.001; compared with the test drug A group, $P<0.05, $$P<0.01, $$$P<0.001

[0049] Figure 5 This graph shows the effect of the test drug on the xylene-induced ear swelling rate in mice.

[0050] In the figure, compared with the model group, *P<0.05, **P<0.01, ***P<0.001; compared with the test drug J group, #P<0.05,

[0051] ##P<0.01, ###P<0.001; compared with test drug group A, $P<0.05, $$P<0.01, $$$P<0.001 DETAILED DESCRIPTION

[0052] The technical solution of the present invention is further described in detail below in conjunction with several preferred embodiments. The following embodiments are implemented on the premise of the technical solution of the invention, and detailed implementation methods and specific operating processes are given, but the protection scope of the present invention is not limited to the following embodiments.

[0053] Example 1 Granule Preparation Method

[0054] 300g of dwarf tea, 150g of fried silkworm, 120g of dried tangerine peel, 150g of ginger and pinellia, 200g of northern adenophora, 150g of licorice (I) Extraction: Take dwarf tea and dried tangerine peel, crush them into 30 mesh particles, add 6 times the amount of water of the medicinal materials, heat and keep it slightly boiling for 6 hours, extract volatile oil by steam distillation, and the volatile oil (stored separately), drug residues and aqueous solution are used for standby; the four flavors of fried silkworm, ginger and pinellia, northern adenophora and licorice and the drug residues after the volatile oil is extracted from the above-mentioned dwarf tea and dried tangerine peel are placed in an extraction tank and decocted twice, the first time adding 6 times the weight of water to decoct for 1.5 hours, the second time adding 5 times the weight of water to decoct for 1 hour, combine the two decoctions, let it stand, filter, and reduce the pressure to concentrate with the aqueous solution after the volatile oil is extracted from the dwarf tea and dried tangerine peel to a relative density of 1.25-1.30 (60°C) for standby. Put it in a vacuum drying oven ≤60°C and vacuum dry it, and crush the dry paste into fine powder for standby.

[0055] (ii) Inclusion of volatile oil: weigh β-cyclodextrin in the ratio of volatile oil to β-cyclodextrin (1:10 g / g), add 4-6 times the weight of water to β-cyclodextrin and grind evenly, pour into a colloid mill, start the machine, slowly and continuously add volatile oil dissolved in an appropriate amount of anhydrous ethanol, grind, and dry in a vacuum at 40°C to obtain the inclusion compound for use.

[0056] (III) Mixing and granulation: Mix the dry paste powder, volatile oil β-cyclodextrin inclusion compound and dextrin, an appropriate amount of water, and 0.5% stevioside to form a soft material, granulate, and dry (≤60° C.) to form 1000 g granules.

[0057] (iv) Granulation: Pass the dried granules through 10-mesh and 50-mesh sieves.

[0058] (V) Packaging: Pack the obtained granules in aluminum foil and divide them into 10g / bags.

[0059] Example 2 Tablet Preparation Method

[0060] 300g of dwarf tea, 150g of stir-fried silkworm, 120g of dried tangerine peel, 150g of ginger pinellia, 200g of northern adenophora, and 150g of liquorice. (I) Extraction: Take dwarf tea and dried tangerine peel, crush them into 30 mesh particles, add 8 times the amount of water of the medicinal materials, heat and keep it slightly boiling for 5 hours, extract volatile oil by steam distillation, and keep the volatile oil (separately stored), medicinal residues and aqueous solution for later use; the stir-fried silkworm, ginger pinellia, northern adenophora and liquorice, the aqueous solution after volatile oil is extracted from the above-mentioned dwarf tea and dried tangerine peel, and the medicinal residues are placed in an extraction tank and decocted twice, the first time adding 6 times the weight of the medicinal materials and decocting for 1.5 hours, the second time adding 7 times the weight of the medicinal materials and decocting for 1 hour, combining the two water extracts, standing, filtering, and reducing pressure and concentrating with the aqueous solution after volatile oil is extracted from the dwarf tea and dried tangerine peel to an extract with a relative density of 1.25-1.30 (60°C), placing in a vacuum drying oven ≤60°C for vacuum drying, and crushing the dry extract into fine powder for later use.

[0061] (ii) Inclusion of volatile oil: Weigh a certain amount of β-cyclodextrin according to the ratio of volatile oil: β-cyclodextrin (1:15g / g), add appropriate amount of β-CD to water and grind evenly, pour into a colloid mill, start the machine, slowly and continuously add volatile oil dissolved in appropriate amount of anhydrous ethanol, grind for a certain period of time, and vacuum dry at 40°C to obtain the inclusion compound for use.

[0062] (III) Mixing, granulation and tableting: Mix the dry paste powder, volatile oil β-cyclodextrin inclusion compound and lactose in appropriate amounts to form a soft material, granulate, dry (≤60°C), add 0.5% magnesium stearate, mix well, and tabletize to prepare 1000 tablets (0.5 g / tablet).

[0063] Embodiment 3 hard capsule preparation method

[0064] 250g of dwarf tea, 180g of stir-fried silkworm, 150g of dried tangerine peel, 150g of ginger pinellia, 230g of northern adenophora, and 150g of liquorice. (I) Extraction: Take dwarf tea and dried tangerine peel, crush them into 30 mesh particles, add 6 times the amount of water of the medicinal materials, heat and keep it slightly boiling for 6 hours, extract volatile oil by steam distillation, and the volatile oil (stored separately), medicinal residues and aqueous solution are used for standby; the stir-fried silkworm, ginger pinellia, northern adenophora and liquorice, the aqueous solution after volatile oil is extracted from the above-mentioned dwarf tea and dried tangerine peel, and the medicinal residues are placed in an extraction tank and decocted twice, the first time adding 6 times the weight of water to decoct for 1.5 hours, the second time adding 5 times the weight of water to decoct for 1 hour, the two decoctions are combined, allowed to stand, filtered, and concentrated under reduced pressure with the aqueous solution after volatile oil is extracted from the dwarf tea and dried tangerine peel to an extract with a relative density of 1.25-1.30 (60°C), placed in a vacuum drying oven ≤60°C for vacuum drying, and the dry paste is crushed into fine powder for standby.

[0065] (ii) Inclusion of volatile oil: Weigh a certain amount of β-cyclodextrin according to the ratio of volatile oil: β-cyclodextrin (1:10g / g), add 4-6 times the weight of water to β-cyclodextrin, grind evenly, pour into a colloid mill, start the machine, slowly and continuously add volatile oil dissolved in an appropriate amount of anhydrous ethanol, grind for a certain period of time, and vacuum dry at 40°C to obtain the inclusion compound for use.

[0066] (III) Mixing, granulation and tableting: Mix the dry paste powder, volatile oil β-cyclodextrin inclusion compound and starch in appropriate amounts to form a soft material, granulate, dry (≤60°C), add 0.5% magnesium stearate, mix well, fill, and make 1000 tablets (0.5g / tablet).

[0067] Embodiment 4 soft capsule preparation method

[0068] 300g of dwarf tea, 150g of stir-fried silkworm, 120g of dried tangerine peel, 150g of ginger pinellia, 200g of northern adenophora, and 150g of liquorice. (I) Extraction: Take dwarf tea and dried tangerine peel, crush them into 30 mesh particles, add 6 times the amount of water of the medicinal materials, heat and keep it slightly boiling for 6 hours, extract volatile oil by steam distillation, and keep the volatile oil (separately stored), medicinal residues and aqueous solution for later use; the stir-fried silkworm, ginger pinellia, northern adenophora and liquorice, the aqueous solution after volatile oil is extracted from the above-mentioned dwarf tea and dried tangerine peel, and the medicinal residues are placed in an extraction tank and decocted twice, the first time adding 6 times the weight of water to decoct for 1.5 hours, the second time adding 5 times the weight of water to decoct for 1 hour, the two decoctions are combined, allowed to stand, filtered, and concentrated under reduced pressure with the aqueous solution after volatile oil is extracted from the dwarf tea and dried tangerine peel to an extract with a relative density of 1.25-1.30 (60°C), placed in a vacuum drying oven ≤60°C for vacuum drying, and the dry paste is crushed into fine powder for later use.

[0069] (ii) Mixed pilling: Evenly mix the dry paste powder, volatile oil and soybean oil (containing 10% lecithin) in appropriate amounts, emulsify and homogenize, degas, and pill (rubber formula: glycerol: water: gelatin: brown iron oxide = 0.5:1.1:1.0:0.003) to make 1000 pills (0.65 g / pill).

[0070] Embodiment 5 Drop pill preparation method

[0071] 300g of dwarf tea, 150g of stir-fried silkworm, 120g of dried tangerine peel, 150g of ginger pinellia, 200g of northern adenophora, and 150g of liquorice. (I) Extraction: Take dwarf tea and dried tangerine peel, crush them into 30 mesh particles, add 6 times the amount of water of the medicinal materials, heat and keep it slightly boiling for 6 hours, extract volatile oil by steam distillation, and keep the volatile oil (separately stored), medicinal residues and aqueous solution for later use; the stir-fried silkworm, ginger pinellia, northern adenophora and liquorice, the aqueous solution after volatile oil is extracted from the above-mentioned dwarf tea and dried tangerine peel, and the medicinal residues are placed in an extraction tank and decocted twice, the first time adding 6 times the weight of water to decoct for 1.5 hours, the second time adding 5 times the weight of water to decoct for 1 hour, the two decoctions are combined, allowed to stand, filtered, and concentrated under reduced pressure with the aqueous solution after volatile oil is extracted from the dwarf tea and dried tangerine peel to an extract with a relative density of 1.25-1.30 (60°C), placed in a vacuum drying oven ≤60°C for vacuum drying, and the dry paste is crushed into fine powder for later use.

[0072] (ii) Mixed dropping pills: Take PEG4000 / PEG6000 (1:1) and heat to melt, then add dry paste powder and volatile oil and mix them evenly. At a liquid temperature of 75°C, a tube temperature of 52°C, a coolant temperature of 8°C (the coolant is dimethyl silicone oil No. 350), a drop distance of 2.5 cm, a drop rate of 25 drops / min, and drop into 1000 dropping pills (pill weight 50 mg).

[0073] Example 6 Tea Bag Preparation Method

[0074] 300g of dwarf tea, 150g of fried silkworm, 120g of dried orange peel, 150g of ginger and pinellia tuber, 200g of northern adenophora, 150g of licorice

[0075] (1) Grinding: Grind six kinds of medicinal materials including dwarf tea into coarse powder, mix evenly, and pack into thin filter paper bags, 5 grams per bag.

[0076] (2) Decoction in water: 1 / 10 of the medicinal formula is one dose, one dose per day.

[0077] Embodiment 7 Acupoint patch preparation method

[0078] 350g of dwarf tea, 200g of stir-fried silkworm, 150g of dried tangerine peel, 120g of ginger pinellia, 230g of northern adenophora, and 120g of liquorice. (I) Extraction: Take dwarf tea and dried tangerine peel, crush them into 30 mesh particles, add 6 times the amount of water of the medicinal materials, heat and keep it slightly boiling for 6 hours, extract volatile oil by steam distillation, and the volatile oil (stored separately), medicinal residues and aqueous solution are used for later use; the stir-fried silkworm, ginger pinellia, northern adenophora and liquorice, the aqueous solution after the volatile oil is extracted from the above-mentioned dwarf tea and dried tangerine peel, and the medicinal residues are placed in an extraction tank and decocted twice, the first time adding 6 times the weight of water and decocting for 1.5 hours, the second time adding 5 times the weight of water and decocting for 1 hour, the two decoctions are combined, allowed to stand, filtered, and concentrated under reduced pressure with the aqueous solution after the volatile oil is extracted from the dwarf tea and dried tangerine peel to an extract with a relative density of 1.25-1.30 (60°C) for later use.

[0079] (ii) Glue mixing: Put the hot melt pressure sensitive adhesive into a material tank, add the extract after gelling at 170℃, keep stirring at 105℃ while vacuuming to remove moisture, stir evenly until there are no bubbles in the colloid, add the penetration enhancer, and continue to stir evenly. (iii) Apply, cut, and make acupuncture patch (2cm in diameter).

[0080] The present invention is further described below by means of efficacy test examples:

[0081] Test Example 1 Antitussive effect of the test drug on ammonia-induced cough in mice

[0082] 1 Experimental Purpose

[0083] To study the antitussive effect of the test drugs.

[0084] 2 Experimental Principle

[0085] Ammonia is an irritating chemical substance. Mice can cough after inhaling ammonia mist. The antitussive effect of the drug can be analyzed by counting the number of coughs in the mice per unit time.

[0086] 3 Experimental Materials

[0087] 3.1 Experimental animals

[0088] SPF-grade ICR mice, 90, were purchased from Jiangsu Huachuang Xinnuo Pharmaceutical Technology Co., Ltd., license number: SCXK(Su)2020-0009, weighing 18-22 g, male.

[0089] 3.2 Experimental equipment

[0090] Stopwatch, syringe, injection needle, gavage needle, filter paper, glass bell jar, stethoscope (Jiangsu Yuanyan Medical Equipment Co., Ltd.), etc.

[0091] 3.3 Experimental reagents

[0092] Concentrated ammonia water (batch number: 220518640E, Nanjing Chemical Reagent Co., Ltd.), sodium carboxymethyl cellulose (batch number: 20220201, Sinopharm Chemical Reagent Co., Ltd.), test drug, dextromethorphan guaifenesin syrup (batch number: 20240411, Harbin Taihua Pharmaceutical Co., Ltd.), etc.

[0093] 4 Methods and steps

[0094] The mice were weighed and marked, and randomly divided into 9 groups, namely the model group, the dextromethorphan guaifenesin syrup group, and the test drug groups J, A, E, F, G, H, and K. The mice in each group were gavaged with the corresponding drug solution for 5 consecutive days. One hour after the last drug administration, the mice were placed in a glass cover with a circular filter paper, and 0.3 ml of ammonia water (25%-28%) was dropped on the filter paper. The number of coughs and the latency period of the mice within 2 minutes were immediately observed and recorded.

[0095] Dosage: Model group, intragastrically administered 0.3% CMC-Na solution (0.2 mL·10 g -1 ) once for 5 consecutive days; Group J (3.82 g·kg -1 )、Group A (4.35 g·kg -1 )、Group E (1.34 g·kg -1 )、Group F (1.05 g·kg -1 ), Group G (1.23 g·kg -1 ), Group H (1.23 g·kg -1 ), Group K (1.23 g·kg -1 ) and dextromethorphan guaifenesin syrup group (7.8 mL kg -1 ), and gavage the corresponding drug suspension (0.2 mL·10 g) prepared with 0.3% CMC-Na solution every day. -1 ) once, and continue to administer for 5 days.

[0096]

[0097] In the following test examples, the dosage ratios of the test drugs J, A, E, F, G, H, and K are the same as in Example 1, and the preparation methods are as follows:

[0098] Preparation method A: Put six ingredients including dwarf tea, fried silkworm, tangerine peel, ginger pinellia, northern adenophora and liquorice in an extraction tank and decoct twice. For the first decoction, add 6 times the amount of water and decoct for 1.5 hours. For the second decoction, add 5 times the amount of water and decoct for 1 hour. Combine the two water extracts, let stand, filter, and concentrate under reduced pressure to an extract with a relative density of 1.25-1.30 (60°C).

[0099] Preparation method J: Take dwarf tea and tangerine peel, crush them into 30 mesh particles, add 6 times the amount of water of the medicinal materials, heat and keep it slightly boiling for 6 hours, extract volatile oil with steam distillation, and keep the volatile oil (separately), medicinal residues and aqueous solution for use; stir-fry silkworm, ginger pinellia, northern adenophora and liquorice, and the medicinal residues after extracting volatile oil from the above-mentioned dwarf tea and tangerine peel are placed in an extraction tank and decocted twice, the first time adding 6 times the amount of water to decoct for 1.5 hours, the second time adding 5 times the amount of water to decoct for 1 hour, combine the two water extracts, let it stand, and filter. Combine the aqueous solution after extracting volatile oil from two flavors such as dwarf tea and tangerine peel, and concentrate under reduced pressure to an extract with a relative density of 1.25-1.30 (60°C). Weigh β-cyclodextrin according to the ratio of volatile oil: β-cyclodextrin (1:10g / g), add β-cyclodextrin to water 4-6 times the weight of β-cyclodextrin, grind evenly, pour into a colloid mill, start the machine, slowly and continuously add volatile oil dissolved in an appropriate amount of anhydrous ethanol, grind, and vacuum dry at 40°C to obtain the inclusion compound for use. Mix the extract and the volatile oil β-cyclodextrin inclusion compound.

[0100] Preparation method E: Take dwarf tea and fried silkworm and put them in an extraction tank, boil them in water twice, add 6 times the amount of water for the first time and boil them for 1.5 hours, add 5 times the amount of water for the second time and boil them for 1 hour, combine the two water extracts, let them stand, filter, and concentrate under reduced pressure to an extract with a relative density of 1.25-1.30 (60℃).

[0101] Preparation method F: Put tangerine peel and ginger pinellia in an extraction tank and decoct them twice. For the first time, add 6 times the amount of water and decoct for 1.5 hours. For the second time, add 5 times the amount of water and decoct for 1 hour. Combine the two water extracts, let stand, filter, and concentrate under reduced pressure to an extract with a relative density of 1.25-1.30 (60°C).

[0102] Preparation method G: Place Adenophora radix and Glycyrrhiza uralensis in an extraction tank and decoct them twice in water. For the first decoction, add 6 times the amount of water and decoct for 1.5 hours. For the second decoction, add 5 times the amount of water and decoct for 1 hour. Combine the two water extracts, let stand, filter, and concentrate under reduced pressure to an extract with a relative density of 1.25-1.30 (60°C).

[0103] Preparation method H: Place the dwarf tea in an extraction tank and boil it in water twice. For the first time, add 6 times the weight of the medicinal material in water and boil it for 1.5 hours. For the second time, add 5 times the weight of the medicinal material in water and boil it for 1 hour. Combine the two water extracts, let stand, filter, and concentrate under reduced pressure to an extract with a relative density of 1.25-1.30 (60°C).

[0104] Preparation method K: Take the fried silkworm pupa and place it in an extraction tank, boil it in water twice, add 6 times the weight of the medicinal material in water for the first time and boil it for 1.5 hours, and add 5 times the weight of the medicinal material in water for the second time and boil it for 1 hour. Combine the two water extracts, let it stand, filter, and concentrate under reduced pressure to an extract with a relative density of 1.25-1.30 (60℃).

[0105] 5 Statistical analysis

[0106] The number of coughs and the latency period of each group of animals within 2 minutes were calculated respectively. One-way ANOVA analysis was performed between groups to test the significance of the difference.

[0107] 6 Experimental results

[0108] like Figure 1 As shown in the figure, compared with the model group, the cough latency of the test drug J, A, E, F, G, H, K and dextromethorphan guaifenesin syrup groups was prolonged to a certain extent, among which the test drug J, A, E, F and dextromethorphan guaifenesin syrup groups had significant differences with the model group. The cough latency of the test drug J and A groups was significantly longer than that of the test drug E, F, G, H, K groups.

[0109] like Figure 2 As shown in the figure, compared with the model group, the cough frequency of the test drug J, A, E, F, G, H, K and dextromethorphan guaifenesin syrup groups all decreased to a certain extent, among which the test drug J, A, E, F and dextromethorphan guaifenesin syrup groups had significant differences with the model group. The cough frequency of the test drug J and A groups was significantly less than that of the test drug E, F, G, H, K groups.

[0110] See Table 1 for data.

[0111] Table 1 Antitussive effect of the tested drugs on ammonia-induced cough in mice ( n=10)

[0112]

[0113] Note: Compared with the model group, *P<0.05, **P<0.01, ***P<0.001; compared with the test drug J group, #P<0.05,

[0114] ##P<0.01, ###P<0.001; compared with the test drug group A, $P<0.05, $$P<0.01, $$P<0.001 Experimental Example 2 Effect of the test drug on the secretion of phenol red in the mouse trachea

[0115] 1 Experimental Purpose

[0116] To study the effect of the test drugs on the phenol red secretion in the mouse trachea and investigate the expectorant effect of the test drugs.

[0117] 2 Experimental Principle

[0118] After the indicator phenol red is injected into the mouse's peritoneum, it can be partially secreted by the bronchi. Expectorant drugs increase the secretion of phenol red from the respiratory mucosa while increasing bronchial secretions. Therefore, the expectorant effect of the drug can be indirectly inferred from the effect of the test drug on the secretion of phenol red in the trachea. Phenol red is red in alkaline solution. After washing out the phenol red in the respiratory tract with sodium bicarbonate solution, it can be quantitatively analyzed by colorimetry.

[0119] 3 Experimental Materials

[0120] 3.1 Experimental animals

[0121] SPF-grade ICR mice, 90, were purchased from Jiangsu Huachuang Xinnuo Pharmaceutical Technology Co., Ltd., license number: SCXK(Su)2020-0009, weighing 18-22 g, male.

[0122] 3.2 Experimental equipment

[0123] Syringes, gavage needles, surgical scissors, ophthalmic forceps, small test tubes, microplate reader (Thermo Fisher Scientific, USA), thumbtacks, No. 7 needles, cotton thread, etc.

[0124] 3.3 Experimental reagents

[0125] 5% sodium bicarbonate solution, 0.25% phenol red solution (accurately weigh 0.25g of phenol red, use 1mol·L -1 Dissolve 2.5 mL of sodium hydroxide solution, add normal saline to 100 mL, and shake well), normal saline (batch number: 2310262, Jiangsu Huaian Shuanghe Pharmaceutical Co., Ltd.), sodium carboxymethyl cellulose (batch number: 20220201, Sinopharm Chemical Reagent Co., Ltd.), test drug, compound platycodon ammonium chloride oral solution (batch number: 231101, Shanghai Meiyu Pharmaceutical Co., Ltd.), etc.

[0126] 4 Methods and steps

[0127] The mice were weighed and marked, and randomly divided into 9 groups, namely the control group, the compound platycodon ammonium chloride oral solution group, and the test drug J, A, E, F, G, H, and K groups. The mice in each group were gavaged with the corresponding drug solution for 5 consecutive days. 30 minutes after the last drug administration, each mouse in each group was intraperitoneally injected with 0.25% phenol red solution 0.5mL. After 30 minutes, the animals were killed by dislocating the cervical vertebra, fixed in the supine position, straightened the neck, and dissected to separate the trachea. A thin cotton thread was passed under the trachea to fix the needle. The blunt No. 7 needle was inserted into the trachea at the thyroid cartilage for 0.3-0.5mm, and fixed with a thread to prevent the needle from slipping. Use a 1mL syringe to connect the needle to push 0.5mL of sodium bicarbonate solution into the trachea, and aspirate back and forth 3 times to irrigate the respiratory tract. Finally, the irrigating fluid was drawn out with a syringe and injected into a test tube. The above method was repeated three times, and about 1.5 mL of the eluate was combined and centrifuged at 1000 rpm for 5 min. The OD value was measured using an enzyme marker (wavelength of 546 nm).

[0128] Dosage: Control group, intragastrically administered 0.3% CMC-Na solution (0.2 mL·10 g -1 ) once for 5 consecutive days; Group J (3.82 g·kg -1 )、Group A (4.35 g·kg -1 )、Group E (1.34 g·kg -1 )、Group F (1.05 g·kg -1 ), Group G (1.23 g·kg -1 ), Group H (1.23 g·kg -1 ), Group K (1.23 g·kg -1 ) and compound platycodon ammonium chloride oral solution group (5.2ml·kg -1 ), and gavage the corresponding drug suspension (0.2 mL·10 g) prepared with 0.3% CMC-Na solution every day. -1 ) once, and continue to administer for 5 days.

[0129] 5 Statistical analysis

[0130] The phenol red concentration of each sample was calculated using the OD value curve of the standard concentration of phenol red solution, and the phenol red concentration of the respiratory tract lavage fluid of each group of animals was calculated respectively. The experimental data were used to calculate the phenol red concentration of each sample. One-way ANOVA analysis was performed between groups to test the significance of the difference.

[0131] 6 Experimental results

[0132] like Figure 3As shown, compared with the control group, the phenol red excretion of the test drug J, A, E, F, G, H, K and compound platycodon ammonium chloride oral solution groups increased to a certain extent, among which the test drug J, A, E, F and compound platycodon ammonium chloride oral solution groups had significant differences from the control group. The phenol red excretion of the test drug J and A groups was significantly higher than that of the test drug E, F, G, H, K groups. The data are shown in Table 2.

[0133] Table 2 Effects of the tested drugs on the secretion of phenol red in the trachea of ​​mice ( n=10)

[0134]

[0135] Note: Compared with the control group, *P<0.05, **P<0.01, ***P<0.001; compared with the test drug J group, #P<0.05,

[0136] ##P<0.01, ###P<0.001; compared with the test drug group A, $P<0.05, $$P<0.01, $$P<0.001 Experimental Example 3 Anti-inflammatory effect of the test drug on xylene-induced ear swelling and inflammation in mice

[0137] 1 Experimental Purpose

[0138] The anti-inflammatory effect of the tested drugs was studied using the xylene-induced ear swelling inflammation model in mice.

[0139] 2 Experimental Principle

[0140] Applying xylene to the ears of mice causes swelling of the ears, triggering an inflammatory response. Since anti-inflammatory drugs can inhibit this response, this model is one of the common methods for screening anti-inflammatory drugs.

[0141] 3 Experimental Materials

[0142] 3.1 Experimental animals

[0143] SPF-grade ICR mice, 90, were purchased from Jiangsu Huachuang Xinnuo Pharmaceutical Technology Co., Ltd., license number: SCXK(Su)2020-0009, weighing 18-22 g, male.

[0144] 3.2 Experimental equipment

[0145] Syringes, injection needles, gavage needles, pipettes (Changsha Womer Technology Co., Ltd.), punchers (Ningbo Deli Co., Ltd.), electronic analytical balances (Sartorius Scientific Instruments Co., Ltd.), etc.

[0146] 3.3 Experimental reagents

[0147] Xylene (batch number: 2200629207F, Nanjing Chemical Reagent Co., Ltd.), normal saline (batch number: 2310262, Jiangsu Huaian Shuanghe Pharmaceutical Co., Ltd.), test drugs, sodium carboxymethyl cellulose (batch number: 20220201, Sinopharm Chemical Reagent Co., Ltd.), indomethacin tablets (batch number: 20220101, Shanghai Jinbuhuan Lankao Pharmaceutical Co., Ltd.), etc.

[0148] 4 Methods and steps

[0149] The mice were weighed and marked, and randomly divided into 9 groups, namely the model group, indomethacin group, and test drug J, A, E, F, G, H, and K groups. The mice in each group were gavaged with the corresponding drug solution for 5 consecutive days. One hour after the last drug administration, 0.03 mL of xylene was applied to the front and back sides of the right ear of each group of mice, and the left ear was not treated. 30 minutes after inflammation, the animals were killed by dislocating the cervical vertebra, and the ears were cut off and a round ear piece was punched in the same part of the ear with an 8mm diameter puncher. The weight was weighed with an electronic balance, and the difference in the weight of the two ears was used as the ear swelling value (g). Swelling rate = (right ear piece weight - left ear piece weight) / left ear piece weight × 100%.

[0150] Dosage: Model group, intragastrically administered 0.3% CMC-Na solution (0.2 mL·10 g -1 ) once for 5 consecutive days; Group J (3.82 g·kg -1 )、Group A (4.35 g·kg -1 )、Group E (1.34 g·kg -1 )、Group F (1.05 g·kg -1 ), Group G (1.23 g·kg -1 ), Group H (1.23 g·kg -1 ), Group K (1.23 g·kg -1 ) and indomethacin group (1.95 mg kg -1 ), and gavage the corresponding drug suspension (0.2 mL·10 g) prepared with 0.3% CMC-Na solution every day. -1 ) once, and continue to administer for 5 days.

[0151] 5 Statistical analysis

[0152] The ear swelling value and swelling rate of each group of animals were calculated respectively. One-way ANOVA analysis was performed between groups to test the significance of the difference.

[0153] 6 Experimental results

[0154] like Figure 4As shown in the figure, compared with the model group, the ear swelling values ​​of the test drug J, A, E, F, G, H, K and indomethacin groups were reduced to a certain extent, and there were significant differences between the test drug J, A, E, F, G, H, K and indomethacin groups and the model group. The ear swelling values ​​of the test drug J and A groups were significantly lower than those of the test drug E, F, G, H, K groups.

[0155] like Figure 5 As shown, compared with the model group, the ear swelling rates of the test drug J, A, E, F, G, H, K and indomethacin groups were all reduced to a certain extent, and there were significant differences between the test drug J, A, E, F, G, H, K and indomethacin groups and the model group. The ear swelling rates of the test drug J and A groups were significantly lower than those of the test drug E, F, G, H, K groups. The data are shown in Table 3.

[0156] Table 3 Anti-inflammatory effect of the tested drugs on xylene-induced ear swelling and inflammation in mice ( n=10)

[0157]

[0158] Note: Compared with the model group, *P<0.05, **P<0.01, ***P<0.001; compared with the test drug J group, #P<0.05,

[0159] ##P<0.01, ###P<0.001; compared with the test drug group A, $P<0.05, $$P<0.01, $$P<0.001 The pharmaceutical composition of the present invention has been clinically tested, and some experimental cases are as follows:

[0160] The tea bag prepared by the method of Example 6 is hereinafter referred to as Linglong Tea.

[0161] 1. Tang Mouqi, female, 7 years old, was hospitalized due to white lung at the end of November 2023 and was discharged on December 16. She began to have a fever of over 39°C on the evening of January 2, accompanied by nasal congestion. On the morning of January 3, she boiled 10 bags of Linglong Tea (5 grams per bag) and drank it three times. Her temperature was over 38°C in the afternoon. Her fever subsided on January 4, and she continued to boil 5 bags of Linglong Tea, and all symptoms disappeared.

[0162] 2. Yu Mouxiu, female, 76 years old, had dizziness, runny nose, itchy throat and cough on December 5, 2024. On the first day, she boiled 2 bags (5 grams per bag) of Linglong tea and drank it as tea, but the effect was not obvious. On the second day, the dosage was increased to 5 bags, and the symptoms were relieved. On the third day, she continued to take 5 bags, and then all symptoms disappeared.

[0163] 3. Han Mouying, female, 70 years old, on March 23, 2023, had headache, fever of 38.6°, severe sore throat, body joint pain, and arrhythmia and shortness of breath. She took 3 packs (15g) of Linglong tea with 300ml of boiled water and went to sleep. When she got up at 2am to urinate, her temperature had dropped to 37.1°, sore throat basically disappeared, and palpitations disappeared but were still accompanied by fatigue and slight dizziness. She continued to drink Linglong tea with 200ml of warm water, and all symptoms disappeared in the morning, with a slight loss of appetite.

[0164] 4. Mao Mouxian, female, 49 years old, was diagnosed with COVID-19 on January 6, 2023. She had a cough with yellow sputum, accompanied by shortness of breath, dizziness and fatigue. Her stool was sheep-dung-like and occurred every 3 days. She took 4 doses of Linglong Tea, twice a day, 200 ml each time. After 4 days, the symptoms of coughing with yellow sputum were greatly reduced, and the dry and hard stools were better than before, with only a slight feeling of fatigue remaining.

[0165] 5. Jin Moulin, male, 59 years old, was diagnosed with COVID-19 on January 11, 2023. He had frequent coughs at night, white sputum, chest tightness and wheezing, body aches, and poor appetite. He was given 5 doses of Linglong Tea, twice a day, 200 ml each time. After 5 days, his cough and sputum were relieved, the aches and pains were gone, and his appetite began to recover.

[0166] 6. Cui Mouying, female, 60 years old, developed choking cough, yellow sputum, chest tightness and shortness of breath on January 6, 2023. She had a history of asthma and a fever of 38.2℃. She was given 5 doses of Linglong Tea, twice a day, 200ml each time. After 5 days, her wheezing was greatly reduced, her body temperature returned to normal, her sputum turned from yellow to white, and the frequency of coughing was reduced compared to before.

[0167] 7. Kong Mouming, male, 59 years old, had a history of chronic obstructive pulmonary disease. After being diagnosed with the new coronavirus on January 10, 2023, he had cough, difficulty and weakness in coughing up sputum, chest tightness and shortness of breath, obvious wheezing, hoarseness in the throat, and loose stools. He was given 5 doses of Linglong Tea, twice a day, 150 ml each time. After taking the medicine, the hoarseness in the throat improved significantly, the sputum was more smooth than before, the chest tightness was better than before, the stool turned from loose to solid, and the intestinal recovery also improved accordingly.

[0168] 8. Shen Mourong, female, 35 years old, developed cough on January 9, 2023, with little sputum, nasal congestion with blood in the nasal cavity, bitter mouth and dry throat, dizziness, fatigue, palpitations, a sense of collapse, and difficulty falling asleep. Linglong Tea 2 doses of Chinese medicine decoction, twice a day, 200ml each time. After 2 days, all symptoms were greatly reduced, the mental state was better than before, and respiratory symptoms such as cough were relieved.

[0169] 9. Zheng Moufang, female, 32 years old, was diagnosed with COVID-19 on December 31, 2022. After three days of self-treatment, her symptoms worsened, with frequent coughing, yellow sputum, dry throat, bowel movements for four days, and yellowish urine. On January 3, 2023, she began to use three doses of Linglong Tea, twice a day, 150 ml each time. After taking the medicine, her coughing, sputum and other discomfort symptoms improved. The nucleic acid test on January 5 turned negative.

[0170] 10. Wang, male, 37 years old, was diagnosed with COVID-19 on December 26, 2023. He is a clinical doctor by profession. He comes into contact with a large number of COVID-19 patients every day and works while sick. He coughs frequently, has yellow sputum and pus, chest tightness and shortness of breath. He took anti-inflammatory drugs, montelukast sodium, and methylprednisolone on his own, but there was no significant improvement. On December 28, he took two doses of Linglong Tea, twice a day, 200 ml each time. The next day, his chest tightness was greatly reduced and the frequency of coughing was reduced compared with before.

[0171] 11. Jiang Moufu, female, 56 years old. In January 2023, a large-scale COVID-19 outbreak occurred. For prevention, the patient used 3 bags of Linglong Tea (15g) to make tea every day. After taking it for 5 days, she felt that her previous symptoms of difficulty falling asleep, shallow sleep and frequent dreams had improved. She continued to use it for 14 days, during which time she did not experience any discomfort such as coughing or sputum.

[0172] 12. Zhou Moulian, female, 47 years old, developed drowsiness, chills, heavy headache, sore throat, nasal congestion, yellow nasal discharge, and body aches on December 8, 2022. The symptoms disappeared after taking one dose of Linglong Tea.

[0173] 13. Hu Moucheng, male, 23 years old, developed severe headache, difficulty sleeping, and diarrhea on December 8, 2022. He took 200 ml of Linglong Tea, and the symptoms were relieved after half an hour.

[0174] 14. Huang Moufeng, female, 52 years old, was diagnosed with COVID-19 on December 20, 2022. She developed symptoms of headache, weak legs, and diarrhea. She took 2 doses of Linglong Tea, twice a day, 200 ml each time. All symptoms were relieved on December 22.

[0175] 15. Ni, female, 45 years old, was diagnosed with COVID-19 on December 21, 2022. She had a fever of 38 degrees and severe headache. She took a dose of Linglong Tea, twice a day, 200 ml each time. The fever subsided and the headache symptoms were relieved that evening.

[0176] 16. Shi Mouxia, female, 40 years old, was diagnosed with COVID-19 on December 21, 2022. She had a fever of 38.4 degrees and symptoms of body pain. She took 3 doses of Linglong Tea, 3 times a day, 200 ml each time. The fever subsided on the second day, and the pain symptoms were relieved on December 23.

[0177] 17. Zhou Mouyin, male, 70 years old, was diagnosed with COVID-19 on December 22, 2022. He had a fever of 38 degrees, accompanied by dizziness, body pain, systolic blood pressure of 80 and 50. He took 3 doses of Linglong Tea, twice a day, 200 ml each time. On December 23, the dizziness improved and the blood pressure returned to 103.60. The symptoms were relieved on December 24.

[0178] 18. Mr. Li, male, 32 years old, was diagnosed with COVID-19 on December 21, 2022. He had a fever of 39.5 degrees and was drowsy. He took 2 doses of Linglong Tea, three times a day, 200 ml each time, and the fever subsided on the next day.

[0179] 19. Hui Moufei, male, 40 years old, was diagnosed with COVID-19 on December 25, 2022, with a fever of 38.7, swollen and painful gums, and headache. He took 2 doses of Linglong Tea, twice a day, 200 ml each time. The fever subsided on the next day and the pain symptoms were relieved.

[0180] 20. Xie Mouqin, female, 30 years old, was diagnosed with COVID-19 on December 22, 2022, with a fever of 38 degrees, accompanied by knee pain, cough, and sore throat. She took 2 doses of Linglong Tea, twice a day, 200 ml each time. The fever subsided and the symptoms were relieved by the afternoon of the next day.

[0181] 21. Chen, female, 40 years old, was diagnosed with COVID-19 on December 30, 2022. She had repeated fever for 3 days, and developed symptoms of chest tightness, shortness of breath, and cough. The cough was accompanied by referred pain in the right chest. She went to the hospital on January 4, 2023 and took 3 doses of Linglong Tea, twice a day, 200 ml each time. Her symptoms improved on January 7, 2023.

Claims

1. A Chinese medicine composition for treating upper respiratory tract infection, characterized in that: The composition is prepared from the following raw materials in parts by weight: 25-35 parts of dwarf tea, 12-20 parts of fried silkworm pupae, 10-15 parts of tangerine peel, 12-20 parts of ginger pinellia, 18-23 parts of northern adenophora, and 12-20 parts of liquorice.

2. The Chinese medicine composition according to claim 1, characterized in that The composition is prepared from the following raw materials in parts by weight: 30 parts of dwarf tea, 15 parts of fried silkworm pupa, 12 parts of tangerine peel, 15 parts of ginger pinellia, 20 parts of northern adenophora, and 15 parts of liquorice.

3. The Chinese medicine composition according to claim 1, characterized in that The composition is prepared into a preparation with pharmaceutically acceptable auxiliary materials.

4. The Chinese medicine composition according to claim 3, characterized in that The preparation is powder, granule, tablet, hard capsule, soft capsule, dripping pill, tea bag and acupoint patch.

5. A method for preparing the Chinese medicine composition according to claim 1 or 2, characterized in that The method comprises the following steps: (1) taking Camellia sinensis and dried orange peel, crushing them into particles, extracting volatile oil by steam distillation, and obtaining volatile oil, medicinal residue and aqueous solution respectively; (2) boiling the four ingredients of fried silkworm, ginger pinellia, northern adenophora and liquorice with the residues of the above-mentioned dwarf safflower and tangerine peel after extracting volatile oil twice, combining the two decoctions, standing, filtering, combining the aqueous solutions of the dwarf safflower and tangerine peel after extracting volatile oil, concentrating under reduced pressure to obtain an extract, vacuum drying to obtain a dry paste, and pulverizing into fine powder; (3) mixing volatile oil and β-cyclodextrin in a weight ratio of 1:10-15 g / g to prepare an inclusion compound; (4) Mixing the fine powder from step (2) and the inclusion compound from step (3).

6. The method according to claim 5, characterized in that The conditions for extracting the volatile oil by steam distillation in step (1) are to add 6-8 times the weight of the medicinal material into water and heat it to keep it slightly boiling for 5-6 hours.

7. The method according to claim 5, characterized in that The decoction conditions in step (2) are as follows: adding 6-8 times the amount of water for the first time and decoct for 1-1.5 hours, and adding 5-7 times the amount of water for the second time and decoct for 1-1.5 hours.

8. The method according to claim 5, characterized in that In step (3), β-cyclodextrin is ground with water and poured into a colloid mill. The colloid mill is started and a volatile oil dissolved in an appropriate amount of anhydrous ethanol is slowly and continuously added dropwise. After grinding, the β-cyclodextrin is vacuum dried at 40-60° C. to obtain an inclusion compound.

9. The method according to claim 5, characterized in that The extract in step (2) is concentrated under reduced pressure to a relative density of 1.25 to 1.30 at 60°C, and vacuum dried at ≤ 60°C. The obtained dry extract is crushed into fine powder.

10. Use of the Chinese medicine composition according to claim 1 in preparing a medicine for treating upper respiratory tract infection.