A medicinal composition for clearing away heat and dampness, and its preparation and application

Abstract

The present invention discloses a medicine composition for clearing away heat and removing dampness, and a preparation and application thereof. The medicine composition for clearing away heat and removing dampness is composed of Polygonum cuspidatum, Verbena officinalis, Gypsum, Talcum, Bupleurum, Scutellaria baicalensis, Artemisia annua, Capillaris, Pinellia ternata, Magnolia officinalis, Patchouli, Amomum villosum, Spider fragrance, Pseudostellaria chinensis, Chao Shenqu, Honeysuckle, Forsythia suspensa, Ginger, and Licorice. The medicine composition for clearing away heat and removing dampness is added with pharmaceutically acceptable excipients to prepare a preparation. The medicine composition for clearing away heat and removing dampness and its preparation can be used to prepare a medicine for treating internal damp-heat syndrome.

Description

Technical Field

[0001] The invention belongs to the field of medicines, and specifically relates to a medicine composition for clearing away pathogenic factors and removing dampness, and a preparation and application thereof. Background Art

[0002] Epidemic cold is a concept in traditional Chinese medicine theory, which refers to an epidemic lung disease that breaks out suddenly, spreads rapidly, infects many people, and causes widespread harm. Typical examples include damp-heat internal accumulation syndrome. Damp-heat internal accumulation syndrome refers to a series of symptoms such as cough, chest tightness and asthma caused by damp-heat blocking the lungs, lung qi failing to be released, qi stagnation, and lung qi going up. This syndrome lacks specific targeted drugs in clinical practice. Western medicine clinical practice usually uses antiviral drugs for treatment, but conventional antiviral drugs are relatively expensive, which brings a heavy economic burden to patients, and many drugs have certain drug resistance and adverse reactions. At the same time, in the clinical application of antiviral drugs, the timing of treatment is crucial. It is best to start antiviral treatment within 48 hours of onset, otherwise, the delayed treatment effect is poor. Therefore, it is very necessary to develop a drug that can effectively treat damp-heat internal accumulation syndrome, is easy to use, safe and has no side effects. Summary of the invention

[0003] In view of the shortcomings of the prior art, the purpose of the present invention is to provide a pharmaceutical composition for clearing away heat and removing dampness, and its preparation and application. The pharmaceutical composition of the present invention has the effects of clearing away heat and dampness, promoting lung function and detoxifying, and aromatic and warding off filth, and can be used to treat internal damp-heat syndrome, with definite efficacy, safety and no toxic side effects.

[0004] The objective of the present invention is achieved through the following technical solutions:

[0005] A medicinal composition for clearing away heat and dampness, comprising the following components by weight: 5-25 parts of Polygonum cuspidatum, 5-25 parts of Verbena officinalis, 5-35 parts of Gypsum, 5-35 parts of Talcum, 5-40 parts of Bupleurum, 3-40 parts of Scutellaria baicalensis, 3-25 parts of Artemisia annua, 3-25 parts of Capillaris, 3-25 parts of Pinellia ternata, 5-25 parts of Magnolia officinalis, 5-40 parts of Patchouli, 5-25 parts of Amomum villosum, 3-25 parts of Spider Ointment, 5-25 parts of Pseudostellaria pseudoginseng, 3-25 parts of stir-fried Shenqu, 5-35 parts of Honeysuckle, 3-25 parts of Forsythia suspensa, 3-20 parts of ginger, and 1-20 parts of Licorice.

[0006] Preferably, the medicinal composition for clearing away heat and dampness is composed of the following components by weight: 10-18 parts of Polygonum cuspidatum, 10-20 parts of Verbena, 12-30 parts of Gypsum, 12-30 parts of Talc, 12-30 parts of Bupleurum, 10-20 parts of Scutellaria baicalensis, 12-20 parts of Artemisia annua, 10-18 parts of Capillaris, 12-20 parts of Pinellia ternata, 10-20 parts of Magnolia officinalis, 10-30 parts of Patchouli, 10-20 parts of Amomum villosum, 10-20 parts of Spider Osmanthus, 10-18 parts of Pseudostellariae, 10-20 parts of Chao Shenqu, 12-22 parts of Honeysuckle, 10-20 parts of Forsythia suspensa, 8-20 parts of ginger, and 6-15 parts of Licorice.

[0007] More preferably, the medicinal composition for clearing away heat and dampness is composed of the following components by weight: 12-18 parts of Polygonum cuspidatum, 12-18 parts of Verbena, 15-25 parts of Gypsum, 15-25 parts of Talc, 15-25 parts of Bupleurum, 12-18 parts of Scutellaria baicalensis, 15-20 parts of Artemisia annua, 12-18 parts of Capillaris, 15-18 parts of Pinellia ternata, 12-18 parts of Magnolia officinalis, 15-25 parts of Patchouli, 12-18 parts of Amomum villosum, 12-20 parts of Spider Osmanthus, 12-15 parts of Pseudostellaria pseudoginseng, 12-18 parts of Chao Shenqu, 15-20 parts of Honeysuckle, 12-16 parts of Forsythia suspensa, 10-16 parts of ginger, and 8-12 parts of Licorice.

[0008] In the prescription, the main medicines are: Polygonum cuspidatum and Verbena officinalis, both of which have the effects of clearing heat and dampness, detoxifying and relieving exterior symptoms, and removing blood stasis. Both of them are cold and cool products, good at clearing internal dampness and relieving internal and external heat. Their detoxifying effect can also treat sore throat, damp-heat and blood stasis. The combination of the two medicines can clear heat, promote dampness and detoxify, and prevent long-term damp-heat and blood stasis.

[0009] The assistant drugs are: both gypsum and talcum powder can clear heat, gypsum is more inclined to enter the middle and upper two Jiao, good at clearing the lung and stomach fire, heavy use of gypsum, clearing the lung and stomach heat syndrome, talcum powder is more inclined to enter the middle and lower Jiao, smooth and soft, so that the heat goes out through urination, and promotes urination to clear the heat of the middle and lower Jiao, and the monarch drugs are combined to clear the whole body's heat, with simple effect and special strength. Bupleurum is bitter and flat, soothes the liver and relieves depression, harmonizes and reduces fever, and Scutellaria baicalensis is bitter and cold, clears heat and dries dampness, and purges fire and detoxifies. Bupleurum purges half-exterior and half-interior external evil, and Scutellaria baicalensis purges half-exterior and half-interior internal evil. The combination of the two can firstly dredge the liver and gallbladder qi mechanism, and secondly clear the damp heat that is depressed inside. Both Artemisia annua and Artemisia capillaris can clear dampness and heat, Artemisia annua is aromatic and pungent, firstly can resolve the depressed heat in the blood, and secondly can invigorate the spleen and stomach to clear yang and guide damp heat; Artemisia capillaris is slightly bitter and cold, good at clearing dampness, and transforming qi downward, Artemisia annua is more aromatic and dries dampness, and transforms qi to the outside. The combination of Bupleurum yunnanensis, Scutellaria baicalensis, Artemisia annua and Capillaris can regulate the qi of the liver and gallbladder and relieve dampness and heat inside and outside the body.

[0010] The adjuvants are: Pinellia ternata, Magnolia officinalis, Patchouli, Amomum villosum, and Spider Odorata, which can work together to dissipate dampness and harmonize the stomach, and can also strengthen the spleen. Among them, Pinellia ternata and Magnolia officinalis are used together, which are pungent and bitter, and can dissipate phlegm and dampness in the three burners. Pseudostellariae and stir-fried Shenqu can strengthen the spleen and digestion, and stir-fried Shenqu can also relieve the exterior. The combination of pungent and warm spleen-strengthening drugs can firstly strengthen the spleen, dissipate dampness and harmonize the stomach, and secondly prevent cold and cool drugs such as Scutellaria baicalensis and Gypsum from damaging the stomach. Honeysuckle and Forsythia suspensa are used together, which are light and clear, good at relieving heat in the upper burner and relieving sore throat.

[0011] The adjuvant drugs are: ginger can relieve exterior symptoms and dispel cold, warm the middle and stop vomiting, and can also detoxify pinellia; licorice can replenish qi and strengthen the spleen, clear away heat and detoxify, and harmonize the properties of the drugs.

[0012] Looking at the whole prescription, it is firstly to clear away heat and relieve the exterior symptoms, detoxify and remove dampness, expel the pathogenic ...

[0013] The medicinal composition for clearing away pathogenic factors and removing dampness can also be added with pharmaceutically acceptable excipients to be made into preparations such as granules, oral liquids, mixtures, tablets, powders, pills, etc.

[0014] The medicinal composition for clearing away pathogenic factors and eliminating dampness and its preparation can be used to prepare medicines for treating internal accumulation of dampness and heat.

[0015] Compared with the prior art, the present invention has the following beneficial effects:

[0016] 1. The present invention aims at the clinical characteristics of epidemic colds, adopts the concept of syndrome differentiation and treatment, gives full play to the advantages of multi-component and multi-target of traditional Chinese medicine compound, implements the overall treatment concept of traditional Chinese medicine of "treating both the symptoms and the root causes, strengthening the body and eliminating evil", and is clinically used to treat internal damp-heat syndrome to achieve significant therapeutic effects, with safety and no toxic side effects.

[0017] 2. In the medicinal composition for clearing away heat and dampness described in the present invention, stir-fried Shenqu can promote the secretion of digestive juice, and has the effects of strengthening the spleen and promoting digestion, and relieving food stagnation; ginger magnolia bark contains a higher content of magnolia bark phenol, which can enhance the effect of relaxing the stomach and eliminating irritation to the throat.

[0018] 3. The present invention also provides a method for preparing the granules of the Qingwen Huashi medicine composition, and the 19 herbs in the prescription are strictly prepared into Qingwen Huashi granules with uniform dosage, uniform specifications and uniform quality standards according to a unified production process and a unified preparation method. It has the advantages of being easy to store, convenient to carry and can be directly taken with water. This medication form can be directly applied to clinical treatment of traditional Chinese medicine, is more suitable for modern clinical medication needs, increases patient acceptability, further popularizes and promotes the clinical application of traditional Chinese medicine, and solves the problems of complex decoction process, long decoction time, and difficulty in storage and carrying of traditional Qingwen Huashi decoction. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 The electron microscopic images of the lung tissues of rats in each group in Application Example 1 are shown.

[0020] Figure 2 Electron microscopic images of AQP1 protein expression in each group of rats in Application Example 1 (in the image, brown-yellow particles represent positive expression of AQP1 protein, and blue particles represent other normal cells, such as red blood cells, neutrophils, etc.).

[0021] Figure 3 Electron microscopic images of AQP5 protein expression in each group of rats in Application Example 1 (in the image, brown-yellow particles represent positive expression of AQP5 protein, and blue particles represent other normal cells, such as red blood cells, neutrophils, etc.). DETAILED DESCRIPTION

[0022] The present invention will be further described below in conjunction with embodiments, but the present invention is not limited to the embodiments. Example 1

[0023] A medicinal composition for clearing away heat and dampness, consisting of the following components: 5g of Polygonum cuspidatum, 5g of Verbena officinalis, 5g of Gypsum, 5g of Talcum, 5g of Bupleurum, 3g of Scutellaria baicalensis, 3g of Artemisia annua, 3g of Capillaris, 3g of Pinellia ternata, 5g of Magnolia officinalis, 5g of Patchouli, 5g of Amomum villosum, 3g of Spider Vinegar, 5g of Pseudostellaria heterophylla, 3g of stir-fried Shenqu, 5g of Honeysuckle, 3g of Forsythia suspensa, 3g of ginger, and 1g of Licorice. Example 2

[0024] A medicinal composition for clearing away heat and dampness, consisting of the following components: 15g of Polygonum cuspidatum, 15g of Verbena officinalis, 20g of Gypsum, 20g of Talcum, 22g of Bupleurum, 21g of Scutellaria baicalensis, 14g of Artemisia annua, 14g of Capillaris, 14g of Pinellia ternata, 15g of Magnolia officinalis, 22g of Patchouli, 15g of Amomum villosum, 14g of Spider Vinegar, 15g of Pseudostellaria pseudoginseng, 14g of stir-fried Shenqu, 20g of Honeysuckle, 14g of Forsythia suspensa, 11g of ginger, and 10g of Licorice. Example 3

[0025] A medicinal composition for clearing away heat and dampness, consisting of the following components: 25g of Polygonum cuspidatum, 25g of Verbena officinalis, 35g of Gypsum, 35g of Talcum, 40g of Bupleurum, 40g of Scutellaria baicalensis, 25g of Artemisia annua, 25g of Capillaris, 25g of Pinellia ternata, 25g of Magnolia officinalis, 40g of Patchouli, 25g of Amomum villosum, 25g of Spider Vinegar, 25g of Pseudostellaria pseudoginseng, 25g of stir-fried Shenqu, 35g of Honeysuckle, 25g of Forsythia suspensa, 20g of ginger, and 20g of Licorice. Example 4

[0026] A medicinal composition for clearing away heat and removing dampness, consisting of the following components: 15g of Polygonum cuspidatum, 12g of Verbena officinalis, 20g of Gypsum, 18g of Talcum, 15g of Bupleurum, 12g of Scutellaria baicalensis, 10g of Artemisia annua, 15g of Capillaris, 15g of Pinellia ternata, 12g of Magnolia officinalis, 15g of Patchouli, 12g of Amomum villosum, 12g of Spider Ointment, 10g of Pseudostellaria pseudoginseng, 12g of stir-fried Shenqu, 15g of Honeysuckle, 12g of Forsythia suspensa, 10g of ginger, and 6g of Licorice. Example 5

[0027] A medicinal composition for clearing away heat and dampness, consisting of the following components: 10g of Polygonum cuspidatum, 12g of Verbena officinalis, 15g of Gypsum, 25g of Talcum, 5g of Bupleurum, 18g of Scutellaria baicalensis, 25g of Artemisia annua, 3g of Capillaris, 12g of Pinellia ternata, 18g of Magnolia officinalis, 12g of Patchouli, 20g of Amomum villosum, 25g of Spider Odor, 12g of Pseudostellaria pseudoginseng, 20g of stir-fried Shenqu, 35g of Honeysuckle, 3g of Forsythia suspensa, 3g of Ginger, and 6g of Licorice. Example 6

[0028] A medicinal composition for clearing away heat and dampness, consisting of the following components: 12g of Polygonum cuspidatum, 18g of Verbena officinalis, 25g of Gypsum, 30g of Talcum, 12g of Bupleurum, 20g of Scutellaria baicalensis, 3g of Artemisia annua, 10g of Capillaris, 15g of Pinellia ternata, 20g of Magnolia officinalis, 15g of Patchouli, 25g of Amomum villosum, 3g of Spider Odor, 18g of Pseudostellaria pseudoginseng, 25g of stir-fried Shenqu, 5g of Honeysuckle, 10g of Forsythia suspensa, 8g of ginger, and 8g of Licorice. Example 7

[0029] A medicinal composition for clearing away heat and dampness, consisting of the following components: 18g of Polygonum cuspidatum, 20g of Verbena officinalis, 30g of Gypsum, 35g of Talcum, 15g of Bupleurum, 40g of Scutellaria baicalensis, 12g of Artemisia annua, 12g of Capillaris, 18g of Pinellia ternata, 5g of Magnolia officinalis, 25g of Patchouli, 10g of Amomum villosum, 10g of Spider Vinegar, 25g of Pseudostellaria pseudoginseng, 3g of stir-fried Shenqu, 12g of Honeysuckle, 12g of Forsythia suspensa, 10g of ginger, and 12g of Licorice. Example 8

[0030] A medicinal composition for clearing away heat and dampness, consisting of the following components: 25g of Polygonum cuspidatum, 5g of Verbena officinalis, 35g of Gypsum, 5g of Talcum, 25g of Bupleurum, 3g of Scutellaria baicalensis, 15g of Artemisia annua, 18g of Capillaris, 20g of Pinellia ternata, 10g of Magnolia officinalis, 30g of Patchouli, 12g of Amomum villosum, 12g of Spider Ointment, 5g of Pseudostellaria pseudoginseng, 10g of stir-fried Shenqu, 18g of Honeysuckle, 16g of Forsythia suspensa, 16g of Ginger, and 20g of Licorice. Example 9

[0031] A medicinal composition for clearing away heat and dampness, consisting of the following components: 5g of Polygonum cuspidatum, 10g of Verbena officinalis, 5g of Gypsum, 15g of Talcum, 30g of Bupleurum, 10g of Scutellaria baicalensis, 20g of Artemisia annua, 25g of Capillaris, 3g of Pinellia ternata, 12g of Magnolia officinalis, 40g of Patchouli, 18g of Amomum villosum, 20g of Spider Odor, 10g of Pseudostellaria pseudoginseng, 18g of stir-fried Shenqu, 22g of Honeysuckle, 25g of Forsythia suspensa, 20g of ginger, and 1g of Licorice. Example 10

[0032] A medicinal composition for clearing away heat and dampness, consisting of the following components: 15g of Polygonum cuspidatum, 25g of Verbena officinalis, 12g of Gypsum, 12g of Talcum, 40g of Bupleurum, 12g of Scutellaria baicalensis, 8g of Artemisia annua, 14g of Capillaris, 25g of Pinellia ternata, 25g of Magnolia officinalis, 5g of Patchouli, 5g of Amomum villosum, 14g of Spider Ointment, 15g of Pseudostellaria pseudoginseng, 12g of stir-fried Shenqu, 30g of Honeysuckle, 20g of Forsythia suspensa, 11g of ginger, and 15g of Licorice. Embodiment 11

[0033] A granule of a pharmaceutical composition for clearing away heat and dampness is prepared by weighing medicinal materials according to the weight of the pharmaceutical composition described in any one of Examples 1-10 and following the steps below:

[0034] (1) Take gypsum, add 1-5 times the total weight of all the medicinal materials in water and boil for 30-40 minutes.

[0035] (2) Add Polygonum cuspidatum, Verbena, Talcum, Bupleurum, Scutellaria, Artemisia annua, Capillaris, Pinellia, Magnolia officinalis, Amomum villosum, Spider Vinegar, Pseudostellaria chinensis, stir-fried Shenqu, Honeysuckle, Forsythia suspensa, ginger and licorice, and add 2-6 times the total weight of all the herbs in water, and continue to boil for 40-50 minutes.

[0036] (3) Add patchouli and 5-8 times the weight of patchouli water, continue decocting for 5-12 minutes, filter, and obtain the first decoction and the residue.

[0037] (4) Add 5-8 times the total weight of all the medicinal materials to the residue and boil for 30-60 minutes. Filter to obtain the second decoction.

[0038] (5) Mix the first decoction and the second decoction, and concentrate under reduced pressure (temperature: 50-80°C, vacuum degree: 0.04-0.10 MPa) to a thick paste with a relative density of 1.25-1.30 (60°C), and set aside.

[0039] (6) Add an equal amount of dextrin to the thick paste, mix well, dry (preferably, at least one of freeze drying, spray drying, reduced pressure drying and pulse vacuum drying), crush, add 0.2 wt% sucralose, and adjust the total amount with dextrin so that each 1000 g of granules contains one dose of crude drug.

[0040] (7) Using 60%-80% ethanol as a wetting agent to prepare granules, drying (preferably, at least one of freeze drying, spray drying, reduced pressure drying and pulse vacuum drying), granulating (preferably, at least one of dry granulation, boiling granulation and wet granulation), and packaging. Example 12

[0041] A mixture of a medicine composition for clearing away heat and removing dampness, wherein the medicine is weighed according to the weight of the medicine composition described in any one of Examples 1-10, and prepared according to the following steps: crush the grass fruit, decoct it with the remaining medicine three times, add water to 10 times the amount of the medicine for the first time, boil it at normal pressure for 60 minutes, and filter it through a 60-mesh filter; add water to 8 times the amount of the medicine for the second time, boil it at normal pressure for 40 minutes, and filter it through a 60-mesh filter; add water to 6 times the amount of the medicine for the third time, boil it at normal pressure for 30 minutes, and filter it through a 60-mesh filter; combine the three filtrates, concentrate under reduced pressure (temperature: 50-80°C, vacuum degree: 0.04-0.10MPa), filter it through a 400-mesh filter, and add purified water to 1000mL. After the semi-finished product is inspected and qualified, it is packaged and sterilized by saturated steam and heat (temperature 110-115°C, pressure>68.6 KPa, sterilization time 30min, end point F0=8-10), and the product is obtained.

[0042] Application Example 1 - Evaluation of the therapeutic effect of the pharmaceutical composition for clearing away heat and dampness of the present invention on rats with viral pneumonia induced by poly(I:C)

[0043] 1. Materials and Methods

[0044] 1. Test drug: Granules prepared from the drug composition for clearing away pathogenic factors and removing dampness described in Examples 1, 2, and 3 according to the method described in Example 11.

[0045] 2. Experimental Animals

[0046] Forty 6-week-old specific pathogen free (SPF) adult healthy SD rats, weighing 180-220 g, half male and half female, were purchased from Sibeifu (Beijing) Biotechnology Co., Ltd., animal license number: SCXK (Beijing) 2019-0010.

[0047] 3. Experimental Reagents

[0048] Polyinosinic-Polycytidylic acid (Poly(I:C), Invivogen, USA, batch number 5934-44-04); aquaporin 1 (AQP1) immunohistochemistry kit (batch number CA000041) and aquaporin 5 (AQP5) rabbit monoclonal antibody (batch number 20334-1-AP) were purchased from Proteintech, USA.

[0049] 4. Experimental Methods

[0050] The animals were divided into the following groups: normal group, model group, Example 1 group, Example 2 group, and Example 3 group, with 8 animals in each group.

[0051] Animal modeling: The normal group was raised in a natural environment (indoor temperature 26±2℃, relative humidity 45%-60%) + ordinary feed, and the other groups were fed with a high-fat feed (80% basic feed + 8% honey + 12% lard) (internal factor). At the same time, they were placed in an artificial climate box with a temperature of (32±0.5)℃ and humidity (90%±5%), and in a humid and hot environment for 8h (9-17 o'clock) every day (external factor). The model was established continuously for 14 days. On the 15th day, 1% sodium pentobarbital was used for intraperitoneal anesthesia, and 50μL Poly(I:C) (5mg / kg, dissolved in 50μL PBS, 1mg / mL) was aspirated with a 1mL syringe and slowly injected into the trachea to establish a viral pneumonia model of damp-heat internal accumulation syndrome. 2 hours after modeling, the normal group and the model group were gavaged with 2 mL / day of normal saline, and the Example 1 group, the Example 2 group, and the Example 3 group were gavaged with the corresponding drugs (the granules were dissolved in water to prepare a solution with a concentration of 0.03 g / mL, and the drug was administered at 0.2 mL / 10 g body weight). All groups were gavaged twice / day for 5 consecutive days. After the last gavage, the rats in each group were fasted but not watered for 12 hours for sample collection, processing, and subsequent detection of related indicators.

[0052] Collection of biological samples: (1) Collection of serum: Three days after the intervention, all rats were fasted for 8 h but not water, and rats were anesthetized by intraperitoneal injection of 1% sodium pentobarbital (10 mL / kg). Blood was collected through the abdominal aorta and centrifuged at 4°C, 3000 r / min for 15 min to collect the upper serum. (2) Collection of BALF and lung tissue: After collecting serum, the rats were killed, the right main bronchus was ligated at the tracheal bifurcation, and 2 mL of cold PBS was slowly injected through the trachea with a syringe to perform bronchoalveolar lavage of the left lung. The left lung was slowly flushed three times with a syringe, and BALF was recovered, which was repeated three times. The collected bronchoalveolar lavage fluid (BALF) was centrifuged at 4°C, 2000 r / min for 10 min, and the supernatant and precipitate were collected respectively. In addition, the right lower lobe tissue was taken for wet-to-dry weight ratio detection; the right middle lobe tissue was fixed in 10% formalin solution for pathological detection; the right upper lobe tissue was weighed and frozen in a -80°C refrigerator for subsequent detection.

[0053] 5. Observation indicators

[0054] During the modeling period, the neatness and brightness of the rats' hair, mental state and activity status, diet and drinking, stool characteristics and weight changes were recorded. After the administration, all rats were anesthetized with 1% sodium pentobarbital and blood was drawn, then killed by cervical dislocation. The changes in the pulmonary capillary barrier (wet / dry (W / D) ratio of lung tissue, total cell count, and total protein concentration) were measured, and the right middle lobe lung tissue was taken for pathological examination. The levels of serum CHOL, LDL-C, and HDL-C in rats were detected by an automatic biochemical analyzer. The expressions of AQP1 and AQP5 in lung tissue were detected.

[0055] 6. Index detection

[0056] 6.1 W / D ratio of lung tissue

[0057] The right lower lobe of the lung was placed on dry weight paper to measure the wet weight (W), and dried in an incubator at 80°C for 48 h to obtain the dry weight (D), and the W / D ratio was calculated.

[0058] 6.2 Total cell count

[0059] Resuspend the BALF pellet with 1 mL of PBS and mix thoroughly using a pipette. Add 10 μL of the cell suspension to a hemocytometer and count the total number of cells at 40 × 10 magnification.

[0060] 6.3 Total protein concentration

[0061] According to the instructions in the kit, BALF supernatant was obtained and the total protein concentration in the BALF supernatant was detected by BCA protein assay.

[0062] 6.4 Lung Histopathological Staining

[0063] The right middle lobe tissues were fixed with 10% formalin solution, dehydrated, embedded in paraffin, and 5-µm sections were stained with hematoxylin and eosin (HE) for pathological analysis.

[0064] 6.5 Determination of CHOL, LDL-C and HDL-C Contents in Rat Serum

[0065] The levels of CHOL, LDL-C and HDL-C in rat serum were detected by automatic biochemical analyzer.

[0066] 6.6 AQP1 and AQP5 expression

[0067] Paraffin sections of right middle lobe tissue were dewaxed to water. The streptavidin-biotin complex (SABC) method was used. 3% hydrogen peroxide (H2O2) was used to inactivate endogenous peroxidase for 5-10 minutes, heat-repaired antigens, serum blocked for 20 minutes, AQP1 and AQP5 primary antibodies were added, and the sections were incubated at 4°C overnight. Goat anti-rabbit IgG (secondary antibody) was added at 37°C for 20 minutes, and SABC was added at 37°C for 20 minutes. The sections were rinsed three times in PBS. Diaminobenzidine (DAB) was used for color development, the sections were sealed, and the sections were photographed under an electron microscope. Results: Positive signals were discolored or brown particles in the cytoplasm and nucleus. Images under the microscope were collected using an image analysis system. Five fields of view were randomly selected for each section under a high-power microscope (400 times), and the images were analyzed using Image-ProPlus Version 5.1 software. The positive cells were scanned in grayscale to determine the average absorbance (A), and the average value was calculated as the representative value of the slice. The average A of the positive cells represented the amount of protein expression.

[0068] 7. Statistical methods

[0069] SPSS28.0 was used to analyze the data. Normal distribution data were analyzed using ( ) indicates that when the data meet the normal distribution and variance homogeneity test, one-way ANOVA is used for inter-group comparison. When the data do not meet the variance homogeneity test, Mann-Whitney U test is used for inter-group comparison. P The difference was significant when the value was less than 0.05.

[0070] 2. Experimental Results

[0071] 1. Animal clinical manifestations

[0072] On the 5th to 7th day of modeling, the rats began to have tangled, dry and dull fur, irritability, constant scratching of the head and face, rapid breathing, laziness, sticky or loose stools with foul odor, red and swollen anus, and reduced food and water intake. After drug administration, the rats still had tangled, dry and dull fur, rapid breathing, laziness, sticky or loose stools with foul odor, red and swollen anus, etc., irritability, the frequency of scratching the head and face decreased, and the amount of food and water intake increased slightly. Sticky or loose stools with foul odor, red and swollen anus were alleviated.

[0073] 2. Changes in pulmonary capillary barrier in rats of each group

[0074] 2.1 Comparison of W / D in lung tissue of rats in each group

[0075] Compared with the normal group, the W / D of the lung tissue of the model group was significantly increased. The W / D of the lung tissue of the model rats in the Example 1, 2, and 3 groups can all significantly reduce the W / D of the lung tissue of the model rats, as shown in Table 1.

[0076]

[0077] 2.2 Comparison of total cell numbers in BALF sediments of rats in each group

[0078] Compared with the normal group, the total cell number in the BALF precipitate of the model group was significantly increased; the total cell number in the BALF precipitate of the model rats in the Example 1, 2, and 3 groups could significantly reduce the total cell number in the BALF precipitate of the model rats, as shown in Table 2.

[0079]

[0080] 2.3 Comparison of total protein concentration in BALF supernatant of rats in each group

[0081] Compared with the normal group, the total protein concentration in the BALF supernatant of the model group rats was significantly increased; both Example 2 and Example 3 groups could reduce the total protein concentration in the BALF supernatant of the model rats, as shown in Table 3.

[0082]

[0083] 3. Pathological changes of rat lung tissue

[0084] like Figure 1 As shown, the bronchial and alveolar structures of the lung tissue of rats in the normal group were intact, and no obvious pulmonary interstitial congestion and inflammatory cell infiltration were observed. In the model group, the alveolar walls in most areas were widened, edematous, the alveolar cavities collapsed, and inflammatory cells infiltrated around the alveolar walls. After intervention in Example 1, 2, and 3, the pathological changes in the lung tissue of rats were significantly alleviated.

[0085] 4. Rat serum CHOL, LDL-C, and HDL-C levels

[0086] Compared with the normal group, the model group had significantly increased serum CHOL and LDL-C levels, and significantly decreased HDL-C levels; the groups of Examples 1, 2, and 3 could significantly reduce the CHOL level of the model rats and increase the HDL-C level; the group of Example 3 could significantly reduce the LDL-C level of the model rats, as shown in Table 4.

[0087]

[0088] 5. Expression of AQP1 and AQP5 proteins in lung tissue

[0089] like Figure 2 , Figure 3 As shown in the figure, AQP1 positive expression is brown-yellow particles, and the main expression sites are the plasma membrane, respiratory zone and alveolar zone of endothelial cells that form vascular barriers along the airways; AQP5 is mainly expressed in bronchiolar epithelial cells and alveolar type I epithelial cells. Compared with the normal group, the expression of AQP1 and AQP5 proteins in the lung tissue of rats in the model group increased significantly; the expression of AQP1 and AQP5 in Example 1, 2 and 3 groups can significantly inhibit the expression of AQP1 and AQP5, and effectively reduce the water metabolism disorder of lung tissue caused by abnormal expression of AQP1 and AQP5, as shown in Table 5.

[0090]

[0091] Conclusion

[0092] Excessive inflammatory response plays an important role in the pathogenesis of viral pneumonia. Under the action of inflammatory mediators, pulmonary capillaries are damaged, permeability increases, pulmonary edema and even bleeding occur, and a large number of inflammatory cells infiltrate, leading to severe pathological damage. It can be seen from Application Example 1 that the preparation of the pharmaceutical composition for clearing away heat and dampness of the present invention can significantly improve the clinical manifestations of viral pneumonia in rats with damp-heat syndrome; reduce the W / D of lung tissue, reduce the total number of cells in BALF sediment, reduce the total protein concentration in BALF, reduce pulmonary capillary damage, and effectively improve the pathological damage of lung tissue in model rats; in addition, it can significantly reduce the CHOL and LDL-C levels of rats in the model group, increase the HDL-C level, and correct abnormal blood lipid metabolism. The study found that the water permeability between alveolar capillaries in mice with AQP1 or AQP5 knockout genes was 1 / 10 of that in normal wild mice, and the water permeability of mice with both AQP1 and AQP5 knockout was only 1 / 25 to 1 / 30 of that in normal mice. AQP5 is also one of the target genes that cause airway hyperresponsiveness. The preparation of the anti-plague and anti-dampness medicine composition of the present invention can significantly inhibit the high expression of AQP1 and AQP5, and effectively reduce the water metabolism disorder of lung tissue caused by abnormal expression of AQP1 and AQP5. The above results all indicate that the anti-plague and anti-dampness medicine composition of the present invention has a good therapeutic effect on viral pneumonia with damp-heat syndrome induced by poly(I:C).

[0093] Application Example 2 - Protective effect of the antipyretic and anti-dampness pharmaceutical composition of the present invention on inflammation and lung injury in rats with viral pneumonia induced by poly(I:C) with internal damp-heat syndrome

[0094] 1. Materials and Methods

[0095] 1. Test drug: The drug composition for clearing away pathogenic factors and removing dampness described in Examples 4, 5, and 6 is prepared according to the method described in Example 12.

[0096] 2. Experimental Animals

[0097] Forty 6-week-old specific pathogen free (SPF) adult healthy SD rats, weighing 180-220 g, half male and half female, were purchased from Sibeifu (Beijing) Biotechnology Co., Ltd., animal license number: SCXK (Beijing) 2019-0010.

[0098] 3. Experimental Reagents

[0099] Polyinosinic-Polycytidylic acid (Poly(I:C), Invivogen, USA, batch number 5934-44-04); Rat IL-4 ELISA kit (Shenzhen Xinbosheng Biotechnology Co., Ltd., batch number ERC002), Rat IL-10 ELISA kit (Shenzhen Xinbosheng Biotechnology Co., Ltd., batch number ERC004); CCL3 Polyclonal Antibody (Invitrogen Life Sciences Inc., USA, batch number 35E27A37), CCR5 Polyclonal Antibody (Invitrogen Life Sciences Inc., USA, 35E29A14).

[0100] 4. Experimental Methods

[0101] The animals were divided into the following groups: normal group, model group, Example 4 group, Example 5 group, and Example 6 group, with 8 animals in each group.

[0102] Animal modeling: The normal group was raised in a natural environment (indoor temperature 26±2℃, relative humidity 45%-60%) + ordinary feed, and the other groups were fed with high-fat feed (80% basic feed + 8% honey + 12% lard) (internal factors). At the same time, they were placed in an artificial climate box with a temperature of (32±0.5)℃ and humidity (90%±5%), and in a humid and hot environment for 8h (9-17 o'clock) every day (external factors). The modeling was continued for 14 days. On the 15th day, 1% sodium pentobarbital was used for intraperitoneal anesthesia, and 50μL Poly(I:C) was aspirated with a 1mL syringe. (5mg / kg, dissolved in 50μL PBS, 1mg / mL) was slowly injected into the trachea to prepare a viral pneumonia model of damp-heat syndrome; 2h after modeling, the normal group and the model group were gavaged with 2mL / day of normal saline, and the Example 4 group, the Example 5 group, and the Example 6 group were gavaged with the corresponding drugs (administered at 0.2mL / 10g body weight), and all groups were gavaged twice / day for 5 consecutive days. After the last gavage, the rats in each group were fasted but not watered for 12h, and samples were collected, processed, and subsequently tested for related indicators.

[0103] Collection of biological samples: The rats were killed, the right main bronchus was ligated at the tracheal bifurcation, and 2 mL of cold PBS was slowly injected through the trachea with a syringe for bronchoalveolar lavage of the left lung. The left lung was slowly flushed 3 times with a syringe, and BALF was recovered, and repeated 3 times. The collected BALF was centrifuged at 4°C and 2000 r / min for 10 min, and the supernatant and precipitate were collected respectively. The right upper lobe tissue was weighed and frozen in a -80°C refrigerator for subsequent testing.

[0104] 5. Observation indicators

[0105] After the administration, all rats were anesthetized with 1% sodium pentobarbital and blood was collected before being killed by cervical dislocation. The levels of IL-4 and IL-10 in the BALF supernatant were detected, and the effects of the preparation on lung tissue cell apoptosis and CCL3 / CCR5 pathway were observed.

[0106] 6. Index detection

[0107] 6.1 Cytokine expression levels

[0108] According to the instructions in the kit, ELISA kit was used to detect the content of IL-4 and IL-10 in BALF supernatant.

[0109] 6.2 CCL3 / CCR5 pathway

[0110] 6.2.1 CCL3 and CCR5 mRNA expression

[0111] Real-time fluorescence quantitative PCR was used for detection. Total mRNA from lung tissue was extracted using an RNA extraction kit, and cDNA was synthesized using a reverse transcription cDNA synthesis kit. The primer sequences are shown in Table 6. The components of the PCR system were 2×SYBR Green Mix: 10 μL, upstream primer (10 μM): 0.4 μL, downstream primer (10 μM): 0.4 μL, template: 2 μL, add sterile distilled water to 20 μL, and use GAPDH as an internal reference. The reaction procedure was pre-denaturation at 95°C for 10 min, denaturation at 95°C for 15 s, annealing / extension at 60°C for 1 min, denaturation, annealing / extension for a total of 45 cycles, with 2 -ΔΔCt The mRNA expression level was obtained by the method.

[0112]

[0113] 6.2.2 CCL3 and CCR5 protein expression

[0114] Detect by Western blot. After extracting total protein from lung tissue, the protein concentration was detected by BCA kit. Mix the protein with loading buffer in a ratio of 4:1, boil at 100℃ for 5min, transfer to the membrane at 200mA constant current after SDS-PAGE electrophoresis, and block with blocking solution for 1h. Add 1:1000 diluted CCL3 and CCR5 primary antibodies and incubate overnight at 4℃ on a shaker. After washing the membrane, add secondary antibody and incubate at room temperature for 1h. After washing the membrane again, add ECL luminescent solution, develop in WB chemiluminescence instrument, and take pictures.

[0115] 6.3 Apoptosis of lung tissue cells

[0116] TUNEL staining was used for detection. First, the embedded rat lung tissue was dewaxed, rehydrated and antigen repaired. Then, the TUNEL reaction kit was used to drop the prepared reaction solution on the specimen, placed in a wet box, and incubated at 37°C for 1 hour. Wash with PBS 3 times, 15 minutes each time, add a suitable concentration of ToPro fluorescent probe for 15 minutes, and then wash with PBS 3 times, 15 minutes each time. Finally, the slide was sealed with neutral resin. TUNEL-positive cells were observed under a fluorescence microscope, and the total number of cells and the number of apoptotic cells were counted (apoptotic cells showed red fluorescence, and normal cells showed blue fluorescence), and the apoptotic index was calculated (apoptotic index = number of apoptotic cells / total number of cells × 100%).

[0117] 7. Data statistical processing methods

[0118] SPSS28.0 was used to analyze the data. Normal distribution data were analyzed using ( ) indicates that when the data meet the normal distribution and variance homogeneity test, one-way ANOVA is used for inter-group comparison. When the data do not meet the variance homogeneity test, Mann-Whitney U test is used for inter-group comparison. P The difference was significant when the value was less than 0.05.

[0119] 2. Experimental Results

[0120] 1. Comparison of IL-4 and IL-10 levels in BALF supernatant of rats in each group

[0121] Compared with the normal group, the levels of IL-4 and IL-10 in the BALF supernatant of the rats in the model group were significantly increased; the levels of IL-4 and IL-10 in the BALF supernatant of the rats in Examples 4, 5, and 6 were all able to reduce the levels of IL-4 and IL-10 in the BALF supernatant of the rats in Example 6, especially the levels of IL-4 and IL-10 in the BALF supernatant of the rats in the model group were significantly reduced to near normal levels, as shown in Table 7.

[0122]

[0123] 2. Effect on apoptosis of lung tissue cells

[0124] Compared with the normal group, the apoptosis of lung tissue cells in the model group rats was significantly increased. The apoptosis of lung tissue cells in the Example 4, 5 and 6 groups were all effectively reduced, as shown in Table 8.

[0125]

[0126] 3. Effects on the CCL3 / CCR5 pathway in viral pneumonia with endogenous damp-heat syndrome

[0127] Compared with the normal group, the expression levels of CCL3 and CCR5 proteins and mRNA in the model group rats were significantly increased; the expression levels of CCL3 and CCR5 proteins and mRNA in the Example 4, 5 and 6 groups were all reduced, especially the Example 6 group was able to significantly reduce the expression levels of CCL3 and CCR5 proteins and mRNA, and inhibit the activation of the CCL3 / CCR5 pathway, as shown in Tables 9 and 10.

[0128]

[0129]

[0130] 3. Experimental Conclusion

[0131] According to the experimental results, the preparation of the pharmaceutical composition for clearing away inflammatory diseases and removing dampness of the present invention can effectively reduce the IL-4 and IL-10 content in the BALF supernatant of rats with viral pneumonia with damp-heat syndrome, making it close to normal levels; and can effectively reduce the apoptosis of lung tissue cells in rats with viral pneumonia with damp-heat syndrome. Current research believes that viral pneumonia can inhibit the migration of inflammatory cells and relieve viral pneumonia by blocking the activation of the CCL3 / CCR5 axis. The preparation of the pharmaceutical composition for clearing away inflammatory diseases and removing dampness of the present invention can better inhibit the activation of the CCL3 / CCR5 pathway and effectively reduce the apoptosis of lung tissue cells.

[0132] Application Example 3 - Therapeutic effect of the antipyretic and anti-dampness medicinal composition of the present invention on influenza with internal damp-heat syndrome

[0133] 1. Materials and Methods

[0134] 1. Subject Screening

[0135] 1.1 Diagnostic criteria

[0136] Diagnostic criteria for influenza in the "Influenza Diagnosis and Treatment Program (2020 Edition)".

[0137] 1.2 Syndrome diagnostic criteria

[0138] Internal retention of damp-heat syndrome: refer to the diagnostic standards for internal retention of damp-heat in the "Standards for Diagnosis and Efficacy of Traditional Chinese Medicine Diseases and Syndromes" (ZY / T001.1-94) and the "Guidelines for Clinical Diagnosis and Treatment of Common Diseases in Traditional Chinese Medicine Internal Medicine" (ZYYXH / T72-2008) to formulate the diagnostic standards for traditional Chinese medicine syndromes.

[0139] Main symptoms: fever; cough; sore throat; headache and body aches; poor appetite and abdominal distension.

[0140] Secondary symptoms: muscle and joint pain; palpitations; loose and uncomfortable stools; mild fever; thirst without desire to drink; sticky mouth; limb fatigue; yellow urine; thick and smelly vaginal discharge.

[0141] Tongue and pulse: red tongue, thick and greasy or yellow and greasy or yellow and white coating, moist and rapid or slippery and rapid pulse.

[0142] The diagnosis can be made if the patient has 2 main symptoms + tongue and pulse, or 1 main symptom + 2 secondary symptoms + tongue and pulse, or 3 secondary symptoms + tongue and pulse.

[0143] 1.3 Inclusion criteria

[0144] Those who meet the diagnostic criteria for influenza in the "Influenza Diagnosis and Treatment Program (2020 Edition)";

[0145] Those who meet the TCM syndrome of internal damp-heat;

[0146] The course of disease is within 48 hours;

[0147] Age range: 18-65 years old, both men and women are welcome;

[0148] Participate in the study voluntarily, sign the informed consent, and follow up regularly.

[0149] 1.4 Exclusion criteria

[0150] Severe or critically ill patients; patients with abnormal liver function; abnormal blood routine indicators; abnormal renal function; pregnant and lactating patients; patients with serious primary diseases of the heart, brain, lung, liver, kidney and blood system, such as viral hepatitis, hemophilia, mental illness, etc.; other diseases or conditions that reduce the possibility of inclusion or complicate inclusion, such as pregnancy, frequent changes in work environment, unstable living environment, etc., which are prone to loss of follow-up; other patients with conditions that affect the safety of medication.

[0151] 1.5 Study Termination

[0152] Those who are allergic to the experimental Chinese medicine;

[0153] Active liver disease (including chronic or active hepatitis B, primary cholestatic cirrhosis, acute liver failure, etc.);

[0154] Maintain hemodialysis or severe renal dysfunction (glomerular filtration rate <15mL / min / 1.73m 2 );

[0155] Severe primary diseases of the hematopoietic system (leukemia, myelodysplastic syndrome, idiopathic thrombocytopenia, etc.);

[0156] Patients with known immunodeficiency, such as those who have received organ or bone marrow transplantation, HIV infection, or have taken immunosuppressants in the past 3 months;

[0157] Participated in other drug clinical trials within 3 months before taking the drug;

[0158] Pregnancy during the trial;

[0159] Subjects who are deemed unsuitable to participate in the study by the researcher, such as those with poor compliance and lack of enthusiasm for treatment, which may lead to loss to follow-up.

[0160] 1.6 Suspension / Exit Criteria

[0161] If allergic reactions or serious adverse events occur, the trial should be stopped according to the doctor's judgment;

[0162] The subjects have poor compliance (compliance with trial medication <80%), or change or add medication on their own during the trial;

[0163] Regardless of the reason, if the patient is unwilling or unable to continue the clinical trial, he or she may request to withdraw from the trial to the attending physician and the trial will be terminated.

[0164] 1.7 Lost to follow-up criteria

[0165] Although the subject did not explicitly request to withdraw from the trial, he no longer received medication and testing and was lost to follow-up.

[0166] 2. General Information

[0167] This study was approved by the Ethics Committee of Yunnan Institute of Traditional Chinese Medicine (YL

[2023] Lun Shen Zi (012)-02). A total of 91 influenza patients who visited the outpatient and emergency departments of Yunnan Hospital of Traditional Chinese Medicine from September 2023 to April 2020 were collected, including 48 cases in the traditional Chinese medicine group and 43 cases in the basic treatment group. There was no statistically significant difference in general data between the two groups ( P >0.05), which are comparable, see Table 11.

[0168]

[0169] 3. Grouping and Dosage Scheme

[0170] According to the principle of voluntariness, patients are divided into groups according to which treatment options they are willing to accept:

[0171] Basic treatment group: After admission, patients will be diagnosed and treated according to the "Influenza Diagnosis and Treatment Program (2020 Edition)" to ensure basic treatment for patients. Physical cooling and antipyretic drugs can be used for patients with high fever. Antitussive and expectorant drugs are given to patients with severe cough and sputum. Oxygen therapy is performed in an appropriate manner according to the degree of hypoxia.

[0172] Traditional Chinese medicine group: On the basis of basic treatment, take the decoction of the medicinal composition for clearing away heat and dampness of the present invention prepared by conventional methods, 200 mL / time, 3 times a day. The specific dosage of the medicine in the prescription is adjusted within the range of the present invention according to the specific conditions of the patient.

[0173] The treatment course for both groups of patients was 7 days.

[0174] 4. Observation indicators

[0175] 4.1 Body temperature recovery rate

[0176] The number of cases whose body temperature dropped to 37.2℃ or below and reached the normal standard at 12, 24, 36, 48, 60, and 72 hours of treatment was recorded. The temperature recovery rate = the number of cases whose temperature reached the normal standard / the total number of cases.

[0177] 4.2 TCM Syndrome Score

[0178] The patients were evaluated by TCM syndrome score before and after treatment. The main symptoms included fever, cough, sore throat, headache and body aches, poor appetite and abdominal distension. Each indicator was divided into 4 levels: none, mild, moderate and severe, and scored 0, 2, 4 and 6 points respectively. The secondary symptoms included muscle and joint pain, palpitations, loose stools, mild fever, thirst without desire to drink more, sticky mouth, limb fatigue, yellow urine, sticky and smelly vaginal discharge, red tongue, thick and greasy or yellow and greasy or yellow and white tongue coating, and soft and rapid or slippery pulse. Each indicator was divided into 4 levels: none, mild, moderate and severe, and scored 0, 1, 2 and 3 points respectively.

[0179] 4.3 TCM Syndrome Efficacy

[0180] Cured: TCM syndrome score decreased by ≥95%; markedly effective: 95%> TCM syndrome score decreased by ≥70%; effective: 70%> TCM syndrome score decreased by ≥30%; ineffective: TCM syndrome score decreased by <30%.

[0181] 4.4 Rate of use of adjuvant therapy

[0182] The number of patients in the two groups who used physical cooling, antipyretic drugs, antitussive and expectorant drugs, and oxygen therapy was recorded. The usage rate = number of cases / total number of people.

[0183] 4.5 Incidence of complications / severe / critical illness

[0184] The number of complications / severe / critical illnesses in the two groups of patients was recorded, and the incidence rate = number of cases / total number of people.

[0185] 4.6 Safety indicators: blood routine, liver and kidney function

[0186] Blood routine, liver and kidney function were checked once before and after treatment.

[0187] 5. Statistical methods

[0188] SPSS 22 was used to analyze the data. Normal distribution data were analyzed using ( ), and non-normal distribution data were represented by Median (P25, P75). The Kolmogorov-Smirnov method was used to test whether the variables obeyed the normal distribution, and paired samples were used for intra-group comparison. t Two independent samples were used for comparison between groups. t The Wilcoxon test was used for intra-group comparison of non-normally distributed data, and the Mann-Whitney U test was used for inter-group comparison. n (%), expressed as χ 2 Check. Take P The difference was statistically significant when the value was less than 0.05.

[0189] 2. Research Results

[0190] 1. Comparison of body temperature recovery rate between the two groups of patients at each time point

[0191] The temperature recovery rate of the Chinese medicine group was better than that of the basic treatment group at each time point, especially at 12h, the difference between the two groups was statistically significant ( P <0.05), see Table 12.

[0192]

[0193] 2. Comparison of TCM syndrome scores between the two groups of patients before and after treatment

[0194] Compared with before treatment, the median TCM syndrome scores of both groups were reduced, and the difference was statistically significant ( P <0.05); after treatment, the median score of TCM syndrome in the TCM group was lower than that in the basic treatment group, and the difference was statistically significant ( P <0.05), see Table 13.

[0195]

[0196] 3. Comparison of TCM syndrome efficacy between the two groups of patients

[0197] The differences in the efficacy of TCM syndrome in the TCM group, including cure, marked effect, and effectiveness, were statistically significant compared with the basic treatment group ( P <0.05), the cure rate of the Chinese medicine group (62.50%) was much higher than that of the basic treatment group (16.28%), see Table 14.

[0198]

[0199] 4. Comparison of the use of adjuvant therapy between the two groups of patients

[0200] The number of cases using physical cooling or antipyretic drugs or antitussive and expectorant drugs or oxygen therapy in the TCM group and the basic treatment group were 10 cases (20.83%) and 15 cases (34.88%), respectively, which was lower in the TCM group than in the basic treatment group.

[0201] 5. Incidence of complications / severe / critical illness

[0202] No complications, severe or critical illness occurred in either group of patients.

[0203] 6. Safety indicators

[0204] There was no statistically significant difference in blood routine, liver function and renal function indexes after treatment compared with those before treatment, and between the two groups after treatment ( P >0.05).

[0205] 3. Experimental Conclusion

[0206] The medicinal composition for clearing away heat and removing dampness of the present invention is used to treat influenza of the syndrome type of internal damp-heat, has good clinical efficacy in shortening the fever time, alleviating TCM syndromes, improving symptoms, reducing auxiliary treatments, etc., and has high clinical safety.

Claims

1. A medicinal composition for clearing away heat and dampness, characterized in that: The invention is composed of the following components by weight: 5-25 parts of Polygonum cuspidatum, 5-25 parts of Verbena, 5-35 parts of Gypsum, 5-35 parts of Talc, 5-40 parts of Bupleurum, 3-40 parts of Scutellaria baicalensis, 3-25 parts of Artemisia annua, 3-25 parts of Capillaris, 3-25 parts of Pinellia ternata, 5-25 parts of Magnolia officinalis, 5-40 parts of Patchouli, 5-25 parts of Amomum villosum, 3-25 parts of Spider Ointment, 5-25 parts of Pseudostellaria pseudoginseng, 3-25 parts of stir-fried Shenqu, 5-35 parts of Honeysuckle, 3-25 parts of Forsythia suspensa, 3-20 parts of ginger and 1-20 parts of Licorice.

2. The pharmaceutical composition for clearing away pathogenic factors and removing dampness according to claim 1, characterized in that: The invention is composed of the following components by weight: 10-18 parts of Polygonum cuspidatum, 10-20 parts of Verbena, 12-30 parts of Gypsum, 12-30 parts of Talc, 12-30 parts of Bupleurum, 10-20 parts of Scutellaria baicalensis, 12-20 parts of Artemisia annua, 10-18 parts of Capillaris, 12-20 parts of Pinellia ternata, 10-20 parts of Magnolia officinalis, 10-30 parts of Patchouli, 10-20 parts of Amomum villosum, 10-20 parts of Spider Ointment, 10-18 parts of Pseudostellaria pseudoginseng, 10-20 parts of stir-fried Shenqu, 12-22 parts of Honeysuckle, 10-20 parts of Forsythia suspensa, 8-20 parts of ginger and 6-15 parts of Licorice.

3. The pharmaceutical composition for clearing away pathogenic factors and removing dampness according to claim 2, characterized in that: The invention is composed of the following components by weight: 12-18 parts of Polygonum cuspidatum, 12-18 parts of Verbena, 15-25 parts of Gypsum, 15-25 parts of Talc, 15-25 parts of Bupleurum, 12-18 parts of Scutellaria baicalensis, 15-20 parts of Artemisia annua, 12-18 parts of Capillaris, 15-18 parts of Pinellia ternata, 12-18 parts of Magnolia officinalis, 15-25 parts of Patchouli, 12-18 parts of Amomum villosum, 12-20 parts of Spider Odor, 12-15 parts of Pseudostellaria pseudoginseng, 12-18 parts of Stir-fried Shenqu, 15-20 parts of Honeysuckle, 12-16 parts of Forsythia suspensa, 10-16 parts of Ginger and 8-12 parts of Licorice.

4. The preparation of the pharmaceutical composition for clearing away pathogenic factors and removing dampness according to any one of claims 1 to 3, characterized in that: The preparation is prepared by adding pharmaceutically acceptable excipients to the medicinal composition for clearing away pathogenic factors and removing dampness.

5. The preparation of the medicinal composition for clearing away pathogenic factors and removing dampness according to claim 4, characterized in that: The preparation is a granule or a mixture.

6. The method for preparing the granules of the medicinal composition for clearing away pathogenic factors and removing dampness according to claim 5, characterized in that: The following steps are involved: (1) Take gypsum, add 1-5 times the total weight of all the medicinal materials in water and boil for 30-40 minutes; (2) Add Polygonum cuspidatum, Verbena, Talc, Bupleurum, Scutellaria, Artemisia annua, Capillaris, Pinellia ternata, Magnolia officinalis, Amomum villosum, Spider Vinegar, Pseudostellaria chinensis, Stir-fried Shenqu, Honeysuckle, Forsythia suspensa, Ginger and Licorice, add 2-6 times the total weight of all the herbs in water, and continue to boil for 40-50 minutes; (3) Add patchouli and 5-8 times the weight of patchouli water, continue decocting for 5-12 minutes, filter, and obtain the first decoction and the residue; (4) Add 5-8 times the total weight of all the medicinal materials to the residue and boil for 30-60 minutes, then filter to obtain the second decoction; (5) Mix the first decoction and the second decoction, and concentrate under reduced pressure at 50-80°C and 0.04-0.10 MPa to a thick paste with a relative density of 1.25-1.30 at 60°C, and set aside; (6) Add an equal amount of dextrin to the thick paste, mix well, dry, crush, add 0.2 wt% sucralose, and adjust the total amount with dextrin so that every 1000 g of granules contains one dose of crude drug; (7) Use 60%-80% ethanol as a wetting agent to form granules, dry, granulate and package.

7. The method for preparing the mixture of the medicinal composition for clearing away pathogenic factors and removing dampness according to claim 5, characterized in that: The following steps are involved: After crushing the cardamom, boil it with the remaining herbs for three times. For the first time, add water to 10 times the amount of the herbs, boil it at normal pressure for 60 minutes, and filter it through a 60-mesh filter. For the second time, add water to 8 times the amount of the herbs, boil it at normal pressure for 40 minutes, and filter it through a 60-mesh filter. For the third time, add water to 6 times the amount of the herbs, boil it at normal pressure for 30 minutes, and filter it through a 60-mesh filter. Combine the three filtrates, concentrate under reduced pressure at 50-80℃ and 0.04-0.10MPa, filter it through a 400-mesh filter, add purified water to the required volume, package it after passing the inspection, and sterilize it.

8. Use of the pharmaceutical composition for clearing away pathogenic factors and removing dampness according to any one of claims 1 to 3, characterized in that: The use of the medicinal composition for clearing away pathogenic factors and removing dampness in preparing a medicine for treating influenza with internal damp-heat syndrome.

9. The use of the preparation of the medicinal composition for clearing away pathogenic factors and removing dampness according to claim 4, characterized in that: The use of the preparation of the medicinal composition for clearing away pathogenic factors and removing dampness in the preparation of medicine for treating influenza with internal damp-heat syndrome.

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