A traditional Chinese medicine composition with soothing and anti-allergic effects, and a preparation method and application thereof

Abstract

The application relates to the technical field of traditional Chinese medicine, and particularly discloses a traditional Chinese medicine composition with soothing and anti-allergy effects, a preparation method and application thereof. The traditional Chinese medicine composition comprises raw materials: Tribulus terrestris, Lemna, Mentha haplocalyx, Bombyx Batryticatus, Semen Haloxylon, cortex Dictamni, Radix Scutellariae, Fructus Gardeniae, Radix Salviae Miltiorrhizae, Radix Paeoniae Alba, Radix Polygoni Multiflori and Radix Glycyrrhizae. The preparation method is as follows: the Mentha haplocalyx, Bombyx Batryticatus, Semen Haloxylon, cortex Dictamni, Radix Scutellariae, Fructus Gardeniae, Radix Salviae Miltiorrhizae, Radix Paeoniae Alba, Radix Polygoni Multiflori and Radix Glycyrrhizae are ground together to obtain a mixed extract; coconut oil is slowly boiled, aloe is added, the fire is turned off after the aloe is melted, the Tribulus terrestris powder and the mixed medicine powder are added while stirring, the Lemna powder and the mixed extract are added after the system temperature is lower than 40 DEG C, the mixture is stirred uniformly, and the mixture is cooled to a paste, and the mixture is placed at room temperature to obtain the traditional Chinese medicine composition. The formula provided by the application can not only effectively deliver the active components of traditional Chinese medicines to the action sites, but also can synergistically act on multiple pathways such as anti-inflammatory and barrier repair, so that the soothing and anti-allergy effects of the composition are significantly enhanced.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, and more specifically, to a traditional Chinese medicine composition with soothing and anti-allergic effects, its preparation method, and its application. Background Technology

[0002] Eczema is an allergic inflammatory skin disease caused by various internal and external factors. Clinically, skin lesions are mainly characterized by papules, vesicles, exudation, and erosion, exhibiting polymorphic changes and a tendency to recur. Its histological features include intercellular edema of the epidermal cells, accompanied by varying degrees of acanthosis and superficial perivascular lymphoid cell infiltration. Patients often experience itching and sleep disturbances, severely impacting their quality of life. Currently, the main medications for treating eczema, an allergic disease, are corticosteroids and antihistamines, requiring long-term use and carrying significant adverse reactions. In recent years, numerous studies have shown that traditional Chinese medicine external therapies play a significant role in treating eczema, with definite efficacy and fewer adverse reactions, attracting the attention of dermatologists.

[0003] However, existing traditional Chinese medicine compositions for eczema not only have a slow onset of action, but long-term use may also lead to side effects such as dependence or decreased skin tolerance. For these reasons, the application scope of traditional Chinese medicine compositions for the above-mentioned diseases is limited.

[0004] Based on the above statements, there is an urgent need to provide a highly efficient traditional Chinese medicine composition that can achieve synergistic effects on multiple targets and soothe and relieve allergies, as well as its preparation method and application. Summary of the Invention

[0005] To address the problems mentioned in the background section, this invention provides a traditional Chinese medicine composition with soothing and anti-allergic effects, its preparation method, and its application.

[0006] A traditional Chinese medicine composition with soothing and anti-allergic effects includes raw materials and a pharmaceutical matrix. The raw materials are composed of the following ingredients in parts by weight: Tribulus terrestris 12-18 parts, Spirodela polyrhiza 10-15 parts, Mentha haplocalyx 5-8 parts, Bombyx mori 10-15 parts, Kochia scoparia 9-12 parts, Dictamnus dasycarpus 8-13 parts, Scutellaria baicalensis 6-10 parts, Gardenia jasminoides 4-8 parts, Salvia miltiorrhiza 2-3 parts, Paeonia lactiflora 1.4-1.8 parts, Polygonum multiflorum 0.8-1.2 parts, and Glycyrrhiza uralensis 0.4-0.6 parts.

[0007] Further, the raw material is composed of the following parts by weight: Tribulus terrestris 14-16 parts, Spirodela polyrhiza 12-13 parts, Mentha haplocalyx 6-7 parts, Bombyx mori 12-13 parts, Kochia scoparia 10-11 parts, Dictamnus dasycarpus 10-11 parts, Scutellaria baicalensis 7-9 parts, Gardenia jasminoides 5-7 parts, Salvia miltiorrhiza 2.4-2.6 parts, Paeonia lactiflora 1.5-1.7 parts, Polygonum multiflorum 0.9-1.1 parts, and Glycyrrhiza uralensis 0.42-0.58 parts.

[0008] Furthermore, the active pharmaceutical ingredient is composed of the following ingredients in parts by weight: 15 parts Tribulus terrestris, 12.5 parts Spirodela polyrhiza, 6.5 parts Mentha haplocalyx, 12.5 parts Bombyx mori, 10.5 parts Kochia scoparia, 10.5 parts Dictamnus dasycarpus, 8 parts Scutellaria baicalensis, 6 parts Gardenia jasminoides, 2.5 parts Salvia miltiorrhiza, 1.6 parts Paeonia lactiflora, 1 part Polygonum multiflorum, and 0.5 parts Glycyrrhiza uralensis.

[0009] Furthermore, the drug matrix comprises the following raw materials in parts by weight: 720-840 parts coconut oil and 186-240 parts aloe vera.

[0010] Furthermore, the drug matrix comprises the following raw materials in parts by weight: 740-800 parts coconut oil and 190-236 parts aloe vera.

[0011] Furthermore, the drug matrix comprises 780 parts coconut oil and 213 parts aloe vera.

[0012] Secondly, the present invention provides a method for preparing a traditional Chinese medicine composition with soothing and anti-allergic effects, using the following technical solution:

[0013] A method for preparing a traditional Chinese medicine composition with soothing and anti-allergic effects includes the following steps:

[0014] Step S1: Grind Tribulus terrestris and duckweed into powder separately to obtain Tribulus terrestris powder and duckweed powder. Grind peppermint, silkworm, Kochia scoparia, Dictamnus dasycarpus, Scutellaria baicalensis, Gardenia jasminoides, Salvia miltiorrhiza, Paeonia lactiflora, Polygonum multiflorum and licorice together into powder to obtain mixed medicinal powder.

[0015] Step S2: Take 60-70 wt% of the mixed powder and extract it by reflux with anhydrous ethanol and deionized water in sequence, then concentrate, dry and pulverize to obtain the mixed extract;

[0016] Step S3: Simmer coconut oil over low heat to 50-60℃, add aloe vera, and turn off the heat after the aloe vera melts. While stirring, add tribulus terrestris powder and 30-40wt% of mixed medicinal powder. Stir until the system temperature is below 40℃, then add duckweed powder and mixed extract, stir evenly, cool to a paste, and let stand at room temperature to obtain a traditional Chinese medicine composition with soothing and anti-allergic effects.

[0017] Further, in step S1, the Tribulus terrestris powder is prepared by the following method: Tribulus terrestris is ground to obtain cleaned Tribulus terrestris, and then wheat bran is roasted over a low heat at a mass ratio of 1-2:12 until the surface turns slightly yellow. The cleaned Tribulus terrestris is then added and roasted together until the surface of the cleaned Tribulus terrestris turns slightly yellow. After cooling, it is crushed and passed through a 100-120 mesh sieve to obtain Tribulus terrestris powder.

[0018] Further, in step S1, the duckweed powder is prepared by the following method: the duckweed is washed, dried, crushed, and passed through a 100-120 mesh sieve to obtain duckweed powder.

[0019] Furthermore, in step S1, the mixed powder is passed through a 100-120 mesh sieve.

[0020] Furthermore, the specific operation steps of step S2 are as follows:

[0021] Take 60-70 wt% of the mixed medicinal powder and reflux extract with anhydrous ethanol 1-3 times. Combine the ethanol extracts and reflux extract with deionized water 1-3 times. Combine the aqueous extracts and concentrate the ethanol and aqueous extracts under reduced pressure to recover the solvent, and obtain a thick paste. Dry the paste, pulverize it, and sieve it to obtain the mixed extract.

[0022] Furthermore, in step S2, the relative density of the paste is 1.36-1.4.

[0023] Furthermore, in step S2, the drying temperature is 60-80℃.

[0024] Furthermore, in step S2, the mesh size of the sieve is 100-120 mesh.

[0025] Furthermore, in step S2, the specific conditions for vacuum concentration are a temperature of 60-70℃ and a vacuum degree of -0.08MPa to -0.06MPa.

[0026] Thirdly, the present invention provides the application of the traditional Chinese medicine composition prepared by the above method in the preparation of a drug for treating eczema.

[0027] Compared with existing technologies, this invention has the following beneficial effects: The formula of this invention is scientific and the proportions are rigorous. Tribulus terrestris is the principal ingredient, which is bitter, pungent, and slightly warm in nature, and enters the liver and lung meridians. It has the effects of calming the liver and dispelling wind, promoting qi and blood circulation, etc. By dispersing wind-heat in the liver meridian and calming liver yang, it fundamentally relieves skin itching caused by liver stagnation and wind-heat in the blood. Duckweed, peppermint, silkworm pupae, Kochia scoparia, and Dictamnus dasycarpus are the assistant ingredients. Duckweed is pungent and cold in nature, and enters the lung meridian, having the effects of dispersing wind-heat; peppermint is pungent and cool in nature, and enters the lung and liver meridians. It has the effects of dispersing wind-heat, clearing the head and eyes, and relieving itching and rashes; Bombyx batryticatus is salty, pungent, and neutral in nature, and enters the liver, lung, and stomach meridians, and has the effects of dispelling wind and relieving pain, resolving phlegm and dissipating nodules; Kochia scoparia is bitter and cold in nature, and enters the bladder and kidney meridians, and has the effects of clearing heat and promoting diuresis, dispelling wind and relieving itching, and antibacterial and anti-inflammatory effects; Dictamnus dasycarpus is bitter and cold in nature, and enters the spleen, stomach, and bladder meridians, and has the effects of clearing heat and drying dampness, dispelling wind and detoxifying; The addition of the above components helps to dispel external wind, calm internal wind, clear heat and remove dampness, and relieve stagnation and dissipate nodules; Scutellaria baicalensis, Gardenia jasminoides, Salvia miltiorrhiza, Paeonia lactiflora, and Polygonum multiflorum are used as adjuvants. Among them, Scutellaria baicalensis is cold in nature and enters the lung, gallbladder, spleen, large intestine, and small intestine meridians, with the effects of clearing heat and drying dampness, purging fire and detoxifying; Gardenia jasminoides is bitter and cold in nature and enters the heart, liver, lung, and stomach meridians, with the effects of purging fire and relieving irritability, clearing heat and promoting diuresis, cooling blood and detoxifying; Salvia miltiorrhiza is bitter and slightly cold in nature and enters the heart and liver meridians, with the effects of promoting blood circulation and removing blood stasis, cooling blood and eliminating carbuncles; Paeonia lactiflora is sweet, pungent, and warm in nature, with the effects of nourishing blood and softening the liver, and calming liver yang; Polygonum multiflorum is bitter, sweet, astringent, and warm in nature and enters the liver, heart, and kidney meridians, with the effects of replenishing essence and blood, nourishing yin and blood, and moisturizing the skin; Licorice is used as the guiding herb. It is sweet and neutral in nature and enters the heart, lung, spleen, and stomach meridians. It has the functions of clearing heat and detoxifying, relieving spasms and pain. Its sweet and neutral nature also harmonizes the properties of the above-mentioned herbs. The synergistic effect of the above components has the functions of clearing heat and cooling blood, nourishing yin and promoting blood circulation, and harmonizing the liver and spleen. Through deep regulation of multiple targets and multiple effects, they can guide and enhance the overall efficacy of the prepared Chinese medicine composition, so that the formula components can work synergistically. This not only ensures the targeting and effectiveness of the Chinese medicine composition, but also significantly improves the physical condition of eczema patients.

[0028] The traditional Chinese medicine composition proposed in this invention uses coconut oil and aloe vera as a matrix. Coconut oil is rich in various saturated fatty acids (such as lauric acid, capric acid, and caprylic acid) and vitamins (such as vitamin E), which not only promote the transdermal absorption of the active ingredients of traditional Chinese medicine, but also have antibacterial and anti-inflammatory properties, inhibiting the growth of harmful bacteria on the skin and creating a cleaner environment for the active ingredients of traditional Chinese medicine. Aloe vera not only has natural antibacterial properties, but also has excellent moisturizing and barrier repair effects. Together, as a drug matrix, both can deliver the active ingredients of traditional Chinese medicine to the site of action more effectively. Through synergistic effects of multiple pathways such as anti-inflammation, antibacterial, and barrier repair, the overall effect of the traditional Chinese medicine composition in relieving soothing and anti-allergy is significantly enhanced, and the efficacy of the traditional Chinese medicine composition is improved, further expanding the application scope of the traditional Chinese medicine composition. Detailed Implementation

[0029] To make the embodiments of the present invention easier to understand, the present invention will be described in detail below with reference to specific embodiments. These embodiments are for illustrative purposes only and are not limited to the application scope of the present invention.

[0030] Where specific techniques or conditions are not specified in the examples, they shall be performed in accordance with the techniques or conditions described in the literature in this field, or in accordance with the product instructions. Reagents or instruments whose manufacturers are not specified are all conventional products that can be purchased through legitimate channels.

[0031] Tribulus terrestris was purchased from Bozhou Ximutang Pharmaceutical Co., Ltd.; Duckweed was purchased from Wenshui Shunkemei Biotechnology Co., Ltd.; Peppermint and Kochia scoparia were both purchased from Bozhou Haosheng Pharmaceutical Sales Co., Ltd.; Bombyx mori was purchased from Bozhou Sansongtang Pharmaceutical Co., Ltd.; Dictamnus dasycarpus was purchased from Bozhou Ruantang Pharmaceutical Co., Ltd.; Scutellaria baicalensis was purchased from Bozhou Ximutang Pharmaceutical Co., Ltd.; Gardenia jasminoides and Salvia miltiorrhiza were both purchased from Bozhou Wufang Jiuru Pharmaceutical Co., Ltd.; Paeonia lactiflora was purchased from Bozhou Linbai Pharmaceutical Co., Ltd.; Polygonum multiflorum was purchased from Bozhou Wuxianbin Chinese Medicinal Herb Planting Co., Ltd.; Glycyrrhiza uralensis was purchased from Bozhou Fuyongtang Pharmaceutical Co., Ltd.; Aloe vera was purchased from Bozhou Deng Dawei Pharmaceutical Co., Ltd.; and coconut oil was commercially available pharmaceutical excipient coconut oil from Xi'an Tianzheng Pharmaceutical Excipients Co., Ltd.

[0032] Examples 1-3 and Comparative Examples 1-5 provide a traditional Chinese medicine composition with soothing and anti-allergic effects and its preparation method.

[0033] Example 1

[0034] This embodiment provides a traditional Chinese medicine composition with soothing and anti-allergic effects, comprising raw materials and a drug matrix. The raw materials are composed of the following parts by weight: 12 parts of Tribulus terrestris, 10 parts of Spirodela polyrhiza, 5 parts of Mentha haplocalyx, 10 parts of Bombyx mori, 9 parts of Kochia scoparia, 8 parts of Dictamnus dasycarpus, 6 parts of Scutellaria baicalensis, 4 parts of Gardenia jasminoides, 2 parts of Salvia miltiorrhiza, 1.4 parts of Paeonia lactiflora, 0.8 parts of Polygonum multiflorum, and 0.4 parts of Glycyrrhiza uralensis. The drug matrix comprises the following parts by weight: 720 parts of coconut oil and 186 parts of Aloe vera.

[0035] A method for preparing a traditional Chinese medicine composition with soothing and anti-allergic effects includes the following steps:

[0036] Step S1: Grind the white tribulus terrestris to obtain clean white tribulus terrestris. Then, at a mass ratio of 1:12, roast wheat bran over a low heat until the surface turns slightly yellow. Pour in the clean white tribulus terrestris and roast together until the surface of the clean white tribulus terrestris turns slightly yellow. After cooling, grind and pass through a 100-mesh sieve to obtain white tribulus terrestris powder.

[0037] The duckweed was washed with deionized water, dried at 60°C, crushed, and passed through a 100-mesh sieve to obtain duckweed powder.

[0038] Peppermint, silkworm, Kochia scoparia, Dictamnus dasycarpus root bark, Scutellaria baicalensis, Gardenia jasminoides, Salvia miltiorrhiza, Paeonia lactiflora, Polygonum multiflorum, and licorice were dried together at 60°C, crushed, and passed through a 100-mesh sieve to obtain a mixed medicinal powder.

[0039] Step S2: Take 60wt% of the mixed medicinal powder at a material-to-liquid ratio of 1:8, add anhydrous ethanol and reflux once, combine the ethanol extracts, add deionized water to the extracted residue at a material-to-liquid ratio of 1:10 and reflux once, combine the aqueous extracts, concentrate the ethanol extract and aqueous extract under reduced pressure at 60℃ and a vacuum degree of -0.06MPa to recover the solvent, and obtain a thick paste with a relative density of 1.36. After drying at 60℃, pulverize and pass through a 100-mesh sieve to obtain the mixed extract;

[0040] Step S3: Simmer coconut oil over low heat to 50°C, add aloe vera, and turn off the heat after the aloe vera melts. While stirring at 80 rpm, add Tribulus terrestris powder and 40 wt% of mixed medicinal powder. Stir until the system temperature reaches 35°C, then add duckweed powder and mixed extract. Control the speed to 700 rpm and stir for 20 minutes until uniform. Cool to a paste and let stand at room temperature for 70 hours to obtain a traditional Chinese medicine composition with soothing and anti-allergic effects.

[0041] Example 2

[0042] This embodiment provides a traditional Chinese medicine composition with soothing and anti-allergic effects, comprising raw materials and a drug matrix. The raw materials are composed of the following ingredients in parts by weight: 15 parts Tribulus terrestris, 12.5 parts Spirodela polyrhiza, 6.5 parts Mentha haplocalyx, 12.5 parts Bombyx mori, 10.5 parts Kochia scoparia, 10.5 parts Dictamnus dasycarpus, 8 parts Scutellaria baicalensis, 6 parts Gardenia jasminoides, 2.5 parts Salvia miltiorrhiza, 1.6 parts Paeonia lactiflora, 1 part Polygonum multiflorum, and 0.5 parts Glycyrrhiza uralensis. The drug matrix comprises the following ingredients in parts by weight: 780 parts coconut oil and 213 parts aloe vera.

[0043] A method for preparing a traditional Chinese medicine composition with soothing and anti-allergic effects includes the following steps:

[0044] Step S1: Grind the white tribulus terrestris to obtain clean white tribulus terrestris. Then, at a mass ratio of 1.5:12, roast wheat bran over a low heat until the surface turns slightly yellow. Pour in the clean white tribulus terrestris and roast together until the surface of the clean white tribulus terrestris turns slightly yellow. After cooling, grind and pass through a 110-mesh sieve to obtain white tribulus terrestris powder.

[0045] The duckweed was washed with deionized water, dried at 65°C, crushed, and passed through a 110-mesh sieve to obtain duckweed powder.

[0046] Peppermint, silkworm, Kochia scoparia, Dictamnus dasycarpus root bark, Scutellaria baicalensis, Gardenia jasminoides, Salvia miltiorrhiza, Paeonia lactiflora, Polygonum multiflorum, and licorice were dried together at 65°C, crushed, and passed through a 110-mesh sieve to obtain a mixed powder.

[0047] Step S2: At a material-to-liquid ratio of 1:9, take 65wt% of the mixed medicinal powder and extract twice with anhydrous ethanol under reflux. Combine the ethanol extracts. At a material-to-liquid ratio of 1:12, extract the residue twice with deionized water under reflux. Combine the aqueous extracts. Concentrate the ethanol extract and aqueous extract under reduced pressure at 65℃ and a vacuum of -0.07MPa to recover the solvent, and obtain a thick paste with a relative density of 1.38. Dry it at 70℃, pulverize it, and pass it through a 110-mesh sieve to obtain the mixed extract.

[0048] Step S3: Simmer coconut oil over low heat to 55°C, add aloe vera, and turn off the heat after the aloe vera melts. While stirring at 90 rpm, add Tribulus terrestris powder and 35 wt% of mixed medicinal powder. Stir until the system temperature reaches 35°C, then add duckweed powder and mixed extract. Control the speed to 750 rpm and stir for 18 minutes until uniform. Cool to a paste and let stand at room temperature for 70 hours to obtain a traditional Chinese medicine composition with soothing and anti-allergic effects.

[0049] Example 3

[0050] This embodiment provides a traditional Chinese medicine composition with soothing and anti-allergic effects, comprising raw materials and a drug matrix. The raw materials are composed of the following parts by weight: 18 parts of Tribulus terrestris, 15 parts of Spirodela polyrhiza, 8 parts of Mentha haplocalyx, 15 parts of Bombyx mori, 12 parts of Kochia scoparia, 13 parts of Dictamnus dasycarpus, 10 parts of Scutellaria baicalensis, 8 parts of Gardenia jasminoides, 3 parts of Salvia miltiorrhiza, 1.8 parts of Paeonia lactiflora, 1.2 parts of Polygonum multiflorum, and 0.6 parts of Glycyrrhiza uralensis. The drug matrix comprises the following parts by weight: 840 parts of coconut oil and 240 parts of Aloe vera.

[0051] A method for preparing a traditional Chinese medicine composition with soothing and anti-allergic effects includes the following steps:

[0052] Step S1: Grind the white tribulus terrestris to obtain clean white tribulus terrestris. Then, at a mass ratio of 2:12, roast wheat bran over a low heat until the surface turns slightly yellow. Pour in the clean white tribulus terrestris and roast together until the surface of the clean white tribulus terrestris turns slightly yellow. After cooling, grind and pass through a 120-mesh sieve to obtain white tribulus terrestris powder.

[0053] The duckweed was washed with deionized water, dried at 70°C, crushed, and passed through a 120-mesh sieve to obtain duckweed powder.

[0054] Peppermint, silkworm, Kochia scoparia, Dictamnus dasycarpus root bark, Scutellaria baicalensis, Gardenia jasminoides, Salvia miltiorrhiza, Paeonia lactiflora, Polygonum multiflorum, and licorice were dried together at 70°C, crushed, and passed through a 120-mesh sieve to obtain a mixed powder.

[0055] Step S2: Take 70wt% of the mixed medicinal powder at a material-to-liquid ratio of 1:10, add anhydrous ethanol and reflux extract three times, combine the ethanol extracts, add deionized water to the extracted residue at a material-to-liquid ratio of 1:14 and reflux extract three times, combine the aqueous extracts, concentrate the ethanol extract and aqueous extract under reduced pressure at a temperature of 75℃ and a vacuum degree of -0.08MPa to recover the solvent, and obtain a thick paste with a relative density of 1.4. Dry it at 80℃, pulverize it, and pass it through a 120-mesh sieve to obtain the mixed extract.

[0056] Step S3: Simmer coconut oil over low heat to 60°C, add aloe vera, and turn off the heat after the aloe vera melts. While stirring at 100 rpm, add Tribulus terrestris powder and 30 wt% of mixed medicinal powder. Stir until the system temperature reaches 35°C, then add duckweed powder and mixed extract. Control the speed to 800 rpm and stir for 16 minutes until uniform. Cool to a paste and let stand at room temperature for 70 hours to obtain a traditional Chinese medicine composition with soothing and anti-allergic effects.

[0057] To verify the therapeutic effect of the traditional Chinese medicine compositions with soothing and anti-allergic effects prepared in Examples 1-3 of this invention, the applicant set up comparative examples 1-5, as follows:

[0058] Comparative Example 1

[0059] This comparative example provides a traditional Chinese medicine composition with soothing and anti-allergic effects, comprising an active ingredient and a drug matrix. The active ingredient is composed of the following ingredients in parts by weight: 22 parts duckweed, 5 parts peppermint, 10 parts silkworm pupae, 9 parts Kochia scoparia, 8 parts Dictamnus dasycarpus, 6 parts Scutellaria baicalensis, 4 parts Gardenia jasminoides, 2 parts Salvia miltiorrhiza, 1.4 parts Paeonia lactiflora, 0.8 parts Polygonum multiflorum, and 0.4 parts Glycyrrhiza uralensis. The drug matrix comprises the following ingredients in parts by weight: 720 parts coconut oil and 186 parts aloe vera.

[0060] A method for preparing a traditional Chinese medicine composition with soothing and anti-allergic effects includes the following steps:

[0061] The duckweed was washed with deionized water, dried at 60°C, crushed, and passed through a 100-mesh sieve to obtain duckweed powder.

[0062] Peppermint, silkworm, Kochia scoparia, Dictamnus dasycarpus root bark, Scutellaria baicalensis, Gardenia jasminoides, Salvia miltiorrhiza, Paeonia lactiflora, Polygonum multiflorum, and licorice were dried together at 60°C, crushed, and passed through a 100-mesh sieve to obtain a mixed medicinal powder.

[0063] Step S2: Take 60wt% of the mixed medicinal powder at a material-to-liquid ratio of 1:8, add anhydrous ethanol and reflux once, combine the ethanol extracts, add deionized water to the extracted residue at a material-to-liquid ratio of 1:10 and reflux once, combine the aqueous extracts, concentrate the ethanol extract and aqueous extract under reduced pressure at 60℃ and a vacuum degree of -0.06MPa to recover the solvent, and obtain a thick paste with a relative density of 1.36. After drying at 60℃, pulverize and pass through a 100-mesh sieve to obtain the mixed extract;

[0064] Step S3: Simmer coconut oil over low heat to 50°C, add aloe vera, and turn off the heat after the aloe vera melts. While stirring at 80 rpm, add 40 wt% of the mixed medicinal powder. Stir until the system temperature reaches 35°C, then add duckweed powder and mixed extract. Control the speed to 700 rpm and stir for 20 minutes until uniform. Cool to a paste and let stand at room temperature for 70 hours to obtain a traditional Chinese medicine composition with soothing and anti-allergic effects.

[0065] Comparative Example 2

[0066] This comparative example provides a traditional Chinese medicine composition with soothing and anti-allergic effects, comprising an active ingredient and a pharmaceutical matrix. The active ingredient is composed of the following ingredients in parts by weight: 22 parts Tribulus terrestris, 5 parts Mentha haplocalyx, 10 parts Bombyx mori, 9 parts Kochia scoparia, 8 parts Dictamnus dasycarpus, 6 parts Scutellaria baicalensis, 4 parts Gardenia jasminoides, 2 parts Salvia miltiorrhiza, 1.4 parts Paeonia lactiflora, 0.8 parts Polygonum multiflorum, and 0.4 parts Glycyrrhiza uralensis. The pharmaceutical matrix comprises the following ingredients in parts by weight: 720 parts coconut oil and 186 parts aloe vera.

[0067] A method for preparing a traditional Chinese medicine composition with soothing and anti-allergic effects includes the following steps:

[0068] Step S1: Grind the white tribulus terrestris to obtain clean white tribulus terrestris. Then, at a mass ratio of 1:12, roast wheat bran over a low heat until the surface turns slightly yellow. Pour in the clean white tribulus terrestris and roast together until the surface of the clean white tribulus terrestris turns slightly yellow. After cooling, grind and pass through a 100-mesh sieve to obtain white tribulus terrestris powder.

[0069] Peppermint, silkworm, Kochia scoparia, Dictamnus dasycarpus root bark, Scutellaria baicalensis, Gardenia jasminoides, Salvia miltiorrhiza, Paeonia lactiflora, Polygonum multiflorum, and licorice were dried together at 60°C, crushed, and passed through a 100-mesh sieve to obtain a mixed medicinal powder.

[0070] Step S2: Take 60wt% of the mixed medicinal powder at a material-to-liquid ratio of 1:8, add anhydrous ethanol and reflux once, combine the ethanol extracts, add deionized water to the extracted residue at a material-to-liquid ratio of 1:10 and reflux once, combine the aqueous extracts, concentrate the ethanol extract and aqueous extract under reduced pressure at 60℃ and a vacuum degree of -0.06MPa to recover the solvent, and obtain a thick paste with a relative density of 1.36. After drying at 60℃, pulverize and pass through a 100-mesh sieve to obtain the mixed extract;

[0071] Step S3: Simmer coconut oil over low heat to 50°C, add aloe vera, and turn off the heat after the aloe vera melts. While stirring at 80 rpm, add Tribulus terrestris powder and 40 wt% of mixed medicinal powder. Stir until the system temperature reaches 35°C, then add the mixed extract. Control the speed to 700 rpm and stir for 20 minutes until uniform. Cool to a paste state and let stand at room temperature for 70 hours to obtain a traditional Chinese medicine composition with soothing and anti-allergic effects.

[0072] Comparative Example 3

[0073] This comparative example provides a traditional Chinese medicine composition with soothing and anti-allergic effects, comprising an active ingredient and a drug matrix. The active ingredient is composed of the following ingredients in parts by weight: 12 parts Tribulus terrestris, 10 parts Spirodela polyrhiza, 5 parts Mentha haplocalyx, 10 parts Bombyx mori, 9 parts Kochia scoparia, 8 parts Dictamnus dasycarpus, 10 parts Gardenia jasminoides, 2 parts Salvia miltiorrhiza, 1.4 parts Paeonia lactiflora, 0.8 parts Polygonum multiflorum, and 0.4 parts Glycyrrhiza uralensis. The drug matrix comprises the following ingredients in parts by weight: 720 parts coconut oil and 186 parts aloe vera.

[0074] A method for preparing a traditional Chinese medicine composition with soothing and anti-allergic effects includes the following steps:

[0075] Step S1: Grind the white tribulus terrestris to obtain clean white tribulus terrestris. Then, at a mass ratio of 1:12, roast wheat bran over a low heat until the surface turns slightly yellow. Pour in the clean white tribulus terrestris and roast together until the surface of the clean white tribulus terrestris turns slightly yellow. After cooling, grind and pass through a 100-mesh sieve to obtain white tribulus terrestris powder.

[0076] The duckweed was washed with deionized water, dried at 60°C, crushed, and passed through a 100-mesh sieve to obtain duckweed powder.

[0077] Peppermint, silkworm, Kochia scoparia, Dictamnus dasycarpus, gardenia, salvia miltiorrhiza, white peony root, Polygonum multiflorum and licorice were dried together at 60℃, crushed and passed through a 100-mesh sieve to obtain mixed medicinal powder.

[0078] Step S2: Take 60wt% of the mixed medicinal powder at a material-to-liquid ratio of 1:8, add anhydrous ethanol and reflux once, combine the ethanol extracts, add deionized water to the extracted residue at a material-to-liquid ratio of 1:10 and reflux once, combine the aqueous extracts, concentrate the ethanol extract and aqueous extract under reduced pressure at 60℃ and a vacuum degree of -0.06MPa to recover the solvent, and obtain a thick paste with a relative density of 1.36. After drying at 60℃, pulverize and pass through a 100-mesh sieve to obtain the mixed extract;

[0079] Step S3: Simmer coconut oil over low heat to 50°C, add aloe vera, and turn off the heat after the aloe vera melts. While stirring at 80 rpm, add Tribulus terrestris powder and 40 wt% of mixed medicinal powder. Stir until the system temperature reaches 35°C, then add duckweed powder and mixed extract. Control the speed to 700 rpm and stir for 20 minutes until uniform. Cool to a paste and let stand at room temperature for 70 hours to obtain a traditional Chinese medicine composition with soothing and anti-allergic effects.

[0080] Comparative Example 4

[0081] This comparative example provides a traditional Chinese medicine composition with soothing and anti-allergic effects, comprising an active ingredient and a pharmaceutical matrix. The active ingredient is composed of the following ingredients in parts by weight: 12 parts Tribulus terrestris, 10 parts Spirodela polyrhiza, 5 parts Mentha haplocalyx, 10 parts Bombyx mori, 9 parts Kochia scoparia, 8 parts Dictamnus dasycarpus, 10 parts Scutellaria baicalensis, 2 parts Salvia miltiorrhiza, 1.4 parts Paeonia lactiflora, 0.8 parts Polygonum multiflorum, and 0.4 parts Glycyrrhiza uralensis. The pharmaceutical matrix comprises the following ingredients in parts by weight: 720 parts coconut oil and 186 parts aloe vera.

[0082] A method for preparing a traditional Chinese medicine composition with soothing and anti-allergic effects includes the following steps:

[0083] Step S1: Grind the white tribulus terrestris to obtain clean white tribulus terrestris. Then, at a mass ratio of 1:12, roast wheat bran over a low heat until the surface turns slightly yellow. Pour in the clean white tribulus terrestris and roast together until the surface of the clean white tribulus terrestris turns slightly yellow. After cooling, grind and pass through a 100-mesh sieve to obtain white tribulus terrestris powder.

[0084] The duckweed was washed with deionized water, dried at 60°C, crushed, and passed through a 100-mesh sieve to obtain duckweed powder.

[0085] Peppermint, silkworm, Kochia scoparia, Dictamnus dasycarpus root bark, Scutellaria baicalensis, Salvia miltiorrhiza, Paeonia lactiflora, Polygonum multiflorum and licorice were dried together at 60℃, crushed and passed through a 100-mesh sieve to obtain mixed medicinal powder;

[0086] Step S2: Take 60wt% of the mixed medicinal powder at a material-to-liquid ratio of 1:8, add anhydrous ethanol and reflux once, combine the ethanol extracts, add deionized water to the extracted residue at a material-to-liquid ratio of 1:10 and reflux once, combine the aqueous extracts, concentrate the ethanol extract and aqueous extract under reduced pressure at 60℃ and a vacuum degree of -0.06MPa to recover the solvent, and obtain a thick paste with a relative density of 1.36. After drying at 60℃, pulverize and pass through a 100-mesh sieve to obtain the mixed extract;

[0087] Step S3: Simmer coconut oil over low heat to 50°C until aloe vera melts, then turn off the heat. While stirring at 80 rpm, add Tribulus terrestris powder and 40 wt% of mixed medicinal powder. Stir until the system temperature reaches 35°C, then add duckweed powder and mixed extract. Control the speed to 700 rpm and stir for 20 minutes until uniform. Cool to a paste consistency and let stand at room temperature for 70 hours to obtain a traditional Chinese medicine composition with soothing and anti-allergic effects.

[0088] Comparative Example 5

[0089] This comparative example provides a traditional Chinese medicine composition with soothing and anti-allergic effects, comprising an active ingredient and a drug matrix. The active ingredient is composed of the following ingredients in parts by weight: 12 parts Tribulus terrestris, 10 parts Spirodela polyrhiza, 5 parts Mentha haplocalyx, 10 parts Bombyx mori, 9 parts Kochia scoparia, 8 parts Dictamnus dasycarpus, 6 parts Scutellaria baicalensis, 4 parts Gardenia jasminoides, 2 parts Salvia miltiorrhiza, 1.4 parts Paeonia lactiflora, 0.8 parts Polygonum multiflorum, and 0.4 parts Glycyrrhiza uralensis. The drug matrix comprises the following ingredients in parts by weight: 720 parts coconut oil and 186 parts aloe vera.

[0090] A method for preparing a traditional Chinese medicine composition with soothing and anti-allergic effects includes the following steps:

[0091] Step S1: Grind the white tribulus terrestris to obtain clean white tribulus terrestris. Then, at a mass ratio of 1:12, roast wheat bran over a low heat until the surface turns slightly yellow. Pour in the clean white tribulus terrestris and roast together until the surface of the clean white tribulus terrestris turns slightly yellow. After cooling, grind and pass through a 100-mesh sieve to obtain white tribulus terrestris powder.

[0092] The duckweed was washed with deionized water, dried at 60°C, crushed, and passed through a 100-mesh sieve to obtain duckweed powder.

[0093] Peppermint, silkworm, Kochia scoparia, Dictamnus dasycarpus root bark, Scutellaria baicalensis, Gardenia jasminoides, Salvia miltiorrhiza, Paeonia lactiflora, Polygonum multiflorum, and licorice were dried together at 60°C, crushed, and passed through a 100-mesh sieve to obtain a mixed medicinal powder.

[0094] Step S2: Take 60wt% of the mixed medicinal powder at a material-to-liquid ratio of 1:8, add anhydrous ethanol and reflux once, combine the ethanol extracts, add deionized water to the extracted residue at a material-to-liquid ratio of 1:10 and reflux once, combine the aqueous extracts, concentrate the ethanol extract and aqueous extract under reduced pressure at 60℃ and a vacuum degree of -0.06MPa to recover the solvent, and obtain a thick paste with a relative density of 1.36. After drying at 60℃, pulverize and pass through a 100-mesh sieve to obtain the mixed extract;

[0095] Step S3: Simmer coconut oil over low heat to 50°C, add white petrolatum, and turn off the heat after the white petrolatum melts. While stirring at 80 rpm, add Tribulus terrestris powder and 40 wt% of mixed medicinal powder. Stir until the system temperature reaches 35°C, then add duckweed powder and mixed extract. Control the speed to 700 rpm and stir for 20 minutes until uniform. Cool to a paste state and let stand at room temperature for 70 hours to obtain a traditional Chinese medicine composition with soothing and anti-allergic effects.

[0096] Performance testing

[0097] The therapeutic effects of the traditional Chinese medicine compositions prepared in Examples 1-3 and Comparative Examples 1-5 of this invention were tested.

[0098] laboratory animals

[0099] One hundred and ten specific pathogen-free SD rats, weighing (200±20.0) g each, were used. All were male and housed individually in cages under artificial light. The room temperature was controlled at 23°C with a relative humidity of 50%, and the housing was well-ventilated. During the experiment, the animals had free access to water and food.

[0100] Model preparation

[0101] All rats were acclimatized for 3 days with normal food and water intake, and the animal housing environment was kept suitable and stable. On the fourth day, the rats were randomly divided into 11 groups of 10 rats each. Except for the blank control group, the remaining rats were used to establish an eczema model.

[0102] Preparation of a rat eczema model: Two days before modeling, skin preparation began. Hair was removed from the rat's abdomen using an electric clipper, covering an area of ​​approximately 2cm × 3cm. The skin was then initially sensitized with 30µL of 5% 2,4-dinitrochlorobenzene. On day 5, a second antigen challenge was performed on a 2cm × 2cm shaved area on the right back, applying 50µL of 0.2% DNCB. A symmetrical shaved area on the left back served as a control without medication. Challenge was repeated every 3 days for a total of 3 days. On day 9, the right back of the rats showed significantly more erythema, edema, papules, erosion, or exudation than the left back, indicating successful modeling.

[0103] Experimental grouping and wound treatment

[0104] One hundred rats that successfully modeled the virus (excluding the control group) were randomly divided into three groups: Example 1-3, Comparative Example 1-5, Model Control Group, and Positive Control Group, with an average of 10 rats in each group. Drug administration began on the second day after successful modeling (day 18 of the experiment).

[0105] Starting on day 10 of the experiment, the sensitized skin of rats in the model control group was coated with 1 mm of petroleum jelly; the sensitized skin of rats in Examples 1-3 and Comparative Examples 1-5 was coated with the traditional Chinese medicine composition prepared in Examples 1-3 and Comparative Examples 1-5 with a thickness of about 1 mm; the sensitized skin of rats in the positive control group was coated with dexamethasone ointment with a concentration of 0.075% with a thickness of about 1 mm. The administration frequency was controlled at once / day, and the administration was carried out continuously for 10 days. No drug was applied to the blank group.

[0106] Observation indicators and detection methods

[0107] On day 21 after modeling, the animals were euthanized by cervical dislocation. Using sterile surgical scissors, skin from the right side of the rat's back inflamed area and symmetrically from the left side in healthy areas were cut off. Skin of equal area was punched out using a 6mm diameter circular punch and weighed using an analytical balance. The degree of skin swelling and inhibition rate were observed and calculated. The results are detailed in Table 1.

[0108]

[0109]

[0110] Statistical methods

[0111] All experimental data are expressed as mean ± standard deviation (±s). Data were processed using SPSS 25.0 software, and one-way ANOVA was used to compare differences between groups. P < 0.05 was considered statistically significant.

[0112] Table 1. Comparison of swelling degree and average inhibition rate among rats in each group (n=10, ±s)

[0113]

[0114] Note: Compared with the model control group, a P<0.01, compared with the positive control group, b P<0.01.

[0115] As shown in Table 1, compared with the model control group, positive control group and comparative groups 1-5, the skin swelling of rats was significantly reduced and the inhibition rate was significantly increased by using the traditional Chinese medicine composition prepared in Examples 1-3. This indicates that the traditional Chinese medicine composition prepared by the present invention has a more significant therapeutic effect on eczema and has broad application prospects in the preparation of drugs for treating eczema.

[0116] This specific embodiment is merely an explanation of the present invention and is not intended to limit the invention. After reading this specification, those skilled in the art can make modifications to this embodiment without contributing any inventive step, but such modifications are protected by patent law as long as they are within the scope of the claims of the present invention.

Claims

1. A traditional Chinese medicine composition with soothing and anti-allergic effects, characterized in that, It is prepared from a raw material and a pharmaceutical matrix. The raw material consists of the following parts by weight: 12-18 parts of Tribulus terrestris, 10-15 parts of Spirodela polyrhiza, 5-8 parts of Mentha haplocalyx, 10-15 parts of Bombyx mori, 9-12 parts of Kochia scoparia, 8-13 parts of Dictamnus dasycarpus, 6-10 parts of Scutellaria baicalensis, 4-8 parts of Gardenia jasminoides, 2-3 parts of Salvia miltiorrhiza, 1.4-1.8 parts of Paeonia lactiflora, 0.8-1.2 parts of Polygonum multiflorum, and 0.4-0.6 parts of Glycyrrhiza uralensis. The pharmaceutical matrix includes the following parts by weight: 720-840 parts of coconut oil and 186-240 parts of Aloe vera.

2. The traditional Chinese medicine composition with soothing and anti-allergic effects according to claim 1, characterized in that, The raw material is composed of the following parts by weight: 15 parts Tribulus terrestris, 12.5 parts Spirodela polyrhiza, 6.5 parts Mentha haplocalyx, 12.5 parts Bombyx mori, 10.5 parts Kochia scoparia, 10.5 parts Dictamnus dasycarpus, 8 parts Scutellaria baicalensis, 6 parts Gardenia jasminoides, 2.5 parts Salvia miltiorrhiza, 1.6 parts Paeonia lactiflora, 1 part Polygonum multiflorum, and 0.5 parts Glycyrrhiza uralensis.

3. The traditional Chinese medicine composition with soothing and anti-allergic effects according to claim 1, characterized in that, The drug matrix comprises 780 parts coconut oil and 213 parts aloe vera.

4. The use of a traditional Chinese medicine composition with soothing and anti-allergic effects as described in any one of claims 1-3 in the preparation of a drug for treating eczema.

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