A pharmaceutical composition for treating eczema-like skin diseases and its preparation method

Abstract

The invention belongs to the technical field of traditional Chinese medicine and relates to a pharmaceutical composition for treating eczema-like skin diseases and a preparation method thereof. The pharmaceutical composition of the present invention comprises the following raw materials in parts by weight: 20-30 parts of Dictamni Cortex, 12-25 parts of Radix Angelicae Sinensis, 5-18 parts of Folium Isatidis, 10-30 parts of Herba Hedyotis Diffusae, 5-15 parts of Sophora Flavescentis, 5-20 parts of Fructus Forsythiae, 10-20 parts of Hibiscus Mucuna Leaves, 1-10 parts of Flos Chrysanthemi Indici, and 2-6 parts of Radix Glycyrrhizae;and the mass ratio of Herba Hedyotis Diffusae, Sophora Flavescentis, Fructus Forsythiae, and Fructus Hibiscus Mucuna is 20-30:10-15:8-10:10-15;also comprising 12-18 parts of Fructus Gardeniae, 10-20 parts of Radix Bupleuri, and 5-10 parts of Flos Magnoliae;the present invention has a simple formula, a strict ratio, and interactions between the components. The obtained pharmaceutical composition has a high remission rate for eczema-like skin diseases, a high cure rate, a low recurrence rate, a small side effect, and a high safety profile, and has broad clinical application prospects.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and more particularly to a pharmaceutical composition for treating eczema-like skin diseases and a preparation method thereof. Background Art

[0002] With socioeconomic development and improvements in people's living standards, the incidence of eczema-related skin diseases is on the rise. Eczema-related skin diseases are considered common and recurrent skin diseases, characterized by polymorphism, symmetry, recurring symptoms, and widespread itching. While not as threatening to human health as cardiovascular and cerebrovascular diseases and cancer, their prevalence, complexity, and difficulty in curing can severely impact patients' quality of life.

[0003] Western medicine is effective in controlling eczema-like skin diseases in terms of controlling symptoms, reducing recurrences, and preventing complications, but there is still no specific cure. Moreover, since eczema-like skin diseases are prone to recurrence and most have a long course of illness, with the frequent and long-term use of Western medicine in clinical practice, tolerance and adverse reaction issues are becoming increasingly prominent.

[0004] Traditional Chinese medicine (TCM) contains a wide range of complex ingredients, with each ingredient typically present in relatively low concentrations. Its comprehensive conditioning benefits are significant, and adverse reactions, particularly acute toxicity, are rare. However, the effectiveness of TCM in treating eczema-related skin conditions is relatively weaker than that of Western medicine.

[0005] Therefore, there is an urgent need to provide a pharmaceutical composition for treating eczema-like skin diseases and a preparation method thereof, so as to enhance the therapeutic effect of eczema-like skin diseases, reduce side effects, and have clinical application value. Summary of the Invention

[0006] In order to solve the problem that existing pharmaceutical compositions have poor effects and large side effects in treating eczema-like skin diseases, the present invention provides a pharmaceutical composition for treating eczema-like skin diseases and a preparation method thereof.

[0007] In a first aspect, the present invention provides a pharmaceutical composition for treating eczema-like skin diseases, which adopts the following technical solution:

[0008] A pharmaceutical composition for treating eczema-related skin diseases comprises Dictamni root bark, Chinese angelica root, Isatis indigotica leaf, Hedyotis diffusa herb, Sophora flavescens, Forsythia suspensa, Hibiscus mutabilis leaf, Chrysanthemum indicum, and raw liquorice.

[0009] Preferably, the pharmaceutical composition comprises the following raw materials in parts by weight: 20-30 parts of Dictamnus cortex, 12-25 parts of Angelica sinensis, 5-18 parts of Isatis indigotica, 10-30 parts of Hedyotis diffusa, 5-15 parts of Sophora flavescens, 5-20 parts of Forsythia suspensa, 10-20 parts of Hibiscus mutabilis leaves, 1-10 parts of Chrysanthemum indicum, and 2-6 parts of raw licorice.

[0010] Preferably, the mass ratio of Hedyotis diffusa, Sophora flavescens, Forsythia suspensa, and Hibiscus mutabilis leaves is 20-30:10-15:8-10:10-15.

[0011] Preferably, the pharmaceutical composition comprises the following raw materials in parts by weight: 25 parts of Dictamnus cortex, 15 parts of Angelica sinensis, 15 parts of Isatis indigotica, 20 parts of Hedyotis diffusa, 15 parts of Sophora flavescens, 8 parts of Forsythia suspensa, 15 parts of Hibiscus mutabilis leaves, 6 parts of Chrysanthemum indicum, and 4 parts of raw licorice.

[0012] Preferably, the pharmaceutical composition further comprises the following raw materials in parts by weight: 12-18 parts of scorched Gardenia jasminoides, 10-20 parts of Bupleurum chinense, and 5-10 parts of Magnolia flos.

[0013] Preferably, the pharmaceutical composition further comprises the following raw materials in parts by weight: 15 parts of scorched Gardenia jasminoides, 15 parts of Bupleurum chinense, and 8 parts of Magnolia flos.

[0014] In a second aspect, the present invention provides a method for preparing the pharmaceutical composition for treating eczema-like skin diseases described in the first aspect, using the following technical solution:

[0015] A method for preparing a pharmaceutical composition for treating eczema-like skin diseases, comprising the following steps:

[0016] Weigh the raw materials according to the formula, mix, grind, add water and boil, collect the decoction, filter and concentrate the filtrate;

[0017] Add pharmaceutical excipients to the obtained concentrate and mix them evenly to obtain the pharmaceutical composition.

[0018] Preferably, the pharmaceutical excipient is at least one of cyclodextrin, vaseline, glycerin, gelatin, and xanthan gum.

[0019] The common pharmacological effects of the Chinese medicinal raw materials selected in the present invention in this field are as follows:

[0020] Dictamni root is bitter and cold in nature, and enters the spleen, stomach, and bladder meridians. The root contains dactylic acid, dillactone, sitosterol, berberine, fenugreek, choline, and campesterol; it also contains campesterol, cyperine, γ-truncatine, and dactylic acid; the above-ground part contains psoralen and zanthoxylum bungeanum toxin; it has the effects of clearing away heat and detoxifying, drying dampness and relieving itching, and has an auxiliary effect in treating local pain and itching caused by eczema.

[0021] Angelica sinensis is sweet, pungent and warm in nature. It can nourish blood, promote blood circulation, dispel wind and relieve itching. It has a good therapeutic effect on eczema caused by blood deficiency, heat and external wind evil.

[0022] Isatis indigotica is the dried leaves of the cruciferous herb Isatis indigotica. The chemical components of Isatis indigotica are mainly divided into alkaloids, organic acids, flavonoids, glycosides, etc. Isatis indigotica has the effects of clearing away heat and detoxifying, cooling blood and eliminating spots. It is mainly used clinically for carbuncle, mumps, rashes, coma, and high fever caused by febrile diseases. It has antiviral, antioxidant, antibacterial, and antipyretic effects, and has a good therapeutic effect on eczema caused by heat toxins.

[0023] Houttuynia cordata is the dried whole herb of Houttuynia cordata, a plant of the genus Hedyotis diffusa of the Rubiaceae family. It is cold in nature, bitter and sweet in taste, and enters the heart, liver, spleen, and large intestine meridians. The whole herb is used as medicine. Houttuynia cordata contains dozens of compounds such as cyclopentadiene ether terpenes, acidic compounds, anthraquinone compounds, volatile components, phenylpropanoids, coumarins and polysaccharides, as well as a variety of trace elements. It has multiple pharmacological activities such as anti-tumor, anti-inflammatory and antibacterial, antioxidant, and immunity-enhancing, and can relieve and treat stubborn eczema and acne.

[0024] Sophora flavescens is cold in nature and bitter in taste. It enters the heart, liver, stomach, large intestine and bladder meridians. The root of Sophora flavescens mainly contains alkaloids and flavonoids, which are used to treat symptoms such as heat dysentery, bloody stool, jaundice and urinary retention, red and white vaginal discharge, vaginal swelling and itching, eczema, wet sores, itchy skin, scabies and leprosy, and external treatment of trichomoniasis vaginitis.

[0025] Forsythia suspensa is the dried fruit of the Oleaceae plant Forsythia suspensa. Depending on the harvest time, it can be divided into "green forsythia" and "old forsythia". It has the effects of clearing heat and detoxifying, reducing swelling and dispersing nodules, and evacuating wind-heat. It mainly contains chemical components such as lignans, phenylethanoid glycosides, flavonoids, terpenes, volatile oils, phenolic acids, etc., and has anti-inflammatory, antibacterial, antiviral, and antioxidant pharmacological activities.

[0026] Hibiscus mutabilis leaves are the dried leaves of Hibiscus mutabilis, also known as frost-resistant leaves and iron hoop powder; Hibiscus mutabilis leaves mainly contain various chemical components such as flavonoids, steroids, anthraquinones, alkaloids, organic acids, volatile oils and trace elements; they have the effects of clearing the lungs and cooling the blood, dissipating heat and detoxifying, reducing swelling and discharging pus, and relieving pain. They are used to treat carbuncles, sore throats, snake bites, burns, red and swollen eyes, and bruises.

[0027] Wild chrysanthemum is the dried head inflorescence of the wild chrysanthemum plant of the Asteraceae family. It is cool in nature, bitter and pungent in taste, and enters the liver and heart meridians. Wild chrysanthemum contains volatile oils and compounds such as terpenes, flavonoids, phenolic acids, polysaccharides, etc., which have the effects of dispelling wind and heat, detoxifying and reducing swelling. It can be used to treat skin itching and redness caused by eczema.

[0028] Raw licorice is slightly cool in nature and has the effects of clearing heat and detoxifying, and harmonizing the properties of medicines. It is often used as an auxiliary treatment for eczema and other skin diseases.

[0029] Scorched Gardenia jasminoides is bitter in taste and cold in nature. It enters the heart, lung and triple burner meridians. It has the effects of clearing away heat and detoxifying, reducing swelling and relieving itching. It can be used to treat skin diseases such as eczema and urticaria.

[0030] Bupleurum has a bitter and flat taste. Its main chemical components include saponins, polysaccharides, volatile oils, flavonoids, coumarins, lignans, etc. It has pharmacological effects such as antipyretic, analgesic, anti-inflammatory, liver-protective, and anti-tumor. Its main ingredients can exert certain antioxidant effects by scavenging free radicals, increasing the activity of antioxidant enzymes, and thus play a role in disease prevention or treatment.

[0031] Magnolia is pungent and warm in nature, and enters the lung and stomach meridians. It contains volatile oils and flavonoids, which have the effect of clearing heat and detoxifying, and can relieve symptoms such as skin itching and eczema.

[0032] The present invention has positive and beneficial effects:

[0033] 1. The pharmaceutical composition of the present invention complies with the principle of "monarch, minister, assistant and envoy" of traditional Chinese medicine, strictly controls the mass ratio of Hedyotis diffusa, Sophora flavescens, Forsythia suspensa and Hibiscus mutabilis leaves, and further adds the compound ingredients of Gardenia jasminoides, Bupleurum chinense and Magnolia officinalis, which has a significant therapeutic effect on eczema-like skin diseases; compared with existing traditional Chinese medicine compositions, it has definite efficacy, therapeutic effect, few side effects and high safety.

[0034] 2. The pharmaceutical compositions of the present invention all use natural Chinese medicinal raw materials, have simple preparation methods, a wide range of raw material sources, low costs, no hormone stimulation and side effects, and have a high relief rate for eczema-like skin diseases, a high cure rate, and a low recurrence rate. DETAILED DESCRIPTION

[0035] The present invention is further described in detail below with reference to the examples.

[0036] Examples 1-7 provide a pharmaceutical composition for treating eczema-like skin diseases and a preparation method thereof.

[0037] Example 1

[0038] A pharmaceutical composition for treating eczema-related skin diseases, the pharmaceutical composition being prepared from the following Chinese medicinal raw materials: Dictamni root bark, Chinese angelica, isatis indigotica leaf, Hedyotis diffusa herb, Sophora flavescens, Forsythia suspensa, Hibiscus mutabilis leaf, Chrysanthemum indicum, and raw licorice, wherein the ingredients include 20g of Dictamni root bark, 12g of Chinese angelica, 5g of isatis indigotica leaf, 20g of Hedyotis diffusa herb, 10g of Sophora flavescens, 8g of Forsythia suspensa, 10g of Hibiscus mutabilis leaf, 1g of Chrysanthemum indicum, and 2g of raw licorice;

[0039] Among them, the mass ratio of Hedyotis diffusa, Sophora flavescens, Forsythia suspensa, and Hibiscus mutabilis leaves is 20:10:8:10;

[0040] The preparation method of the pharmaceutical composition comprises the following steps:

[0041] S1. According to the recipe, weigh the raw materials, mix them, grind them, pass them through a 300-mesh sieve, add 1000 mL of water, and boil them at 80°C for 3 h. Collect the decoction, filter it, and concentrate the filtrate to 100 mL;

[0042] S2. Add 15 g of pharmaceutical excipients to the obtained concentrate and mix well to obtain the pharmaceutical composition;

[0043] The pharmaceutical excipients are obtained by mixing cyclodextrin, glycerol and xanthan gum in a mass ratio of 1:1:1.

[0044] Example 2

[0045] A pharmaceutical composition for treating eczema-related skin diseases, the pharmaceutical composition being prepared from the following Chinese medicinal raw materials: Dictamni root bark, Chinese angelica, Isatis indigotica leaf, Hedyotis diffusa, Sophora flavescens, Forsythia suspensa, Hibiscus mutabilis leaf, Chrysanthemum indicum, and raw licorice, wherein: Dictamni root bark 25g, Chinese angelica 15g, Isatis indigotica leaf 10g, Hedyotis diffusa 25g, Sophora flavescens 12g, Forsythia suspensa 9g, Hibiscus mutabilis leaf 13g, Chrysanthemum indicum, and raw licorice 4g;

[0046] Among them, the mass ratio of Hedyotis diffusa, Sophora flavescens, Forsythia suspensa, and Hibiscus mutabilis leaves is 24:12:9:13.

[0047] The preparation method of the pharmaceutical composition comprises the following steps:

[0048] S1. According to the recipe, weigh the raw materials, mix them, grind them, pass them through a 300-mesh sieve, add 1000 mL of water, and boil them at 80°C for 3 h. Collect the decoction, filter it, and concentrate the filtrate to 100 mL;

[0049] S2. Add 15 g of pharmaceutical excipients to the obtained concentrate and mix well to obtain the pharmaceutical composition;

[0050] The pharmaceutical excipients are obtained by mixing cyclodextrin, glycerol and xanthan gum in a mass ratio of 1:1:1.

[0051] Example 3

[0052] A pharmaceutical composition for treating eczema-related skin diseases, the pharmaceutical composition being prepared from the following Chinese medicinal raw materials: Dictamni root bark, Chinese angelica, Isatis indigotica leaf, Hedyotis diffusa, Sophora flavescens, Forsythia suspensa, Hibiscus mutabilis leaf, Chrysanthemum indicum, and raw licorice, wherein: Dictamni root bark 30g, Chinese angelica 25g, Isatis indigotica leaf 18g, Hedyotis diffusa 30g, Sophora flavescens 15g, Forsythia suspensa 10g, Hibiscus mutabilis leaf 15g, Chrysanthemum indicum, and raw licorice 6g;

[0053] Among them, the mass ratio of Hedyotis diffusa, Sophora flavescens, Forsythia suspensa, and Hibiscus mutabilis leaves is 30:15:10:15.

[0054] The preparation method of the pharmaceutical composition comprises the following steps:

[0055] S1. According to the recipe, weigh the raw materials, mix them, grind them, pass them through a 300-mesh sieve, add 1000 mL of water, and boil them at 80°C for 3 h. Collect the decoction, filter it, and concentrate the filtrate to 100 mL;

[0056] S2. Add 15 g of pharmaceutical excipients to the obtained concentrate and mix well to obtain the pharmaceutical composition;

[0057] The pharmaceutical excipients are obtained by mixing cyclodextrin, glycerol and xanthan gum in a mass ratio of 1:1:1.

[0058] Example 4

[0059] A pharmaceutical composition for treating eczema-related skin diseases, the pharmaceutical composition being prepared from the following Chinese medicinal raw materials: Dictamni root bark, Chinese angelica, Isatis indigotica leaf, Hedyotis diffusa, Sophora flavescens, Forsythia suspensa, Hibiscus mutabilis leaf, Chrysanthemum indicum, and raw licorice, wherein: Dictamni root bark 25g, Chinese angelica 15g, Isatis indigotica leaf 15g, Hedyotis diffusa 20g, Sophora flavescens 15g, Forsythia suspensa 8g, Hibiscus mutabilis leaf 15g, Chrysanthemum indicum, and raw licorice 4g;

[0060] Among them, the mass ratio of Hedyotis diffusa, Sophora flavescens, Forsythia suspensa, and Hibiscus mutabilis leaves is 20:15:8:15.

[0061] The preparation method of the pharmaceutical composition comprises the following steps:

[0062] S1. According to the recipe, weigh the raw materials, mix them, grind them, pass them through a 300-mesh sieve, add 1000 mL of water, and boil them at 80°C for 3 h. Collect the decoction, filter it, and concentrate the filtrate to 100 mL;

[0063] S2. Add 15 g of pharmaceutical excipients to the obtained concentrate and mix well to obtain the pharmaceutical composition;

[0064] Among them, the pharmaceutical excipients are obtained by mixing cyclodextrin, glycerol and xanthan gum in a mass ratio of 1:1:1.

[0065] Example 5

[0066] A pharmaceutical composition for treating eczema-related skin diseases, the pharmaceutical composition being prepared from the following Chinese medicinal raw materials: Dictamni root bark, Chinese angelica, Isatis indigotica leaf, Hedyotis diffusa, Sophora flavescens, Forsythia suspensa, Hibiscus mutabilis leaf, Chrysanthemum indica, raw licorice, scorched Gardenia jasminoides, Bupleurum chinense, and Magnolia flos, wherein the ingredients include 25g of Dictamni root bark, 15g of Chinese angelica, 15g of Isatis indigotica leaf, 20g of Hedyotis diffusa, 15g of Sophora flavescens, 8g of Forsythia suspensa, 15g of Hibiscus mutabilis leaf, 6g of Chrysanthemum indica, 4g of raw licorice, 12g of scorched Gardenia jasminoides, 10g of Bupleurum chinense, and 5g of Magnolia flos;

[0067] Among them, the mass ratio of Hedyotis diffusa, Sophora flavescens, Forsythia suspensa, and Hibiscus mutabilis leaves is 20:15:8:15.

[0068] The preparation method of the pharmaceutical composition comprises the following steps:

[0069] S1. According to the recipe, weigh the raw materials, mix them, grind them, pass them through a 300-mesh sieve, add 1000 mL of water, and boil them at 80°C for 3 h. Collect the decoction, filter it, and concentrate the filtrate to 100 mL;

[0070] S2. Add 15 g of pharmaceutical excipients to the obtained concentrate and mix well to obtain the pharmaceutical composition;

[0071] The pharmaceutical excipients are obtained by mixing cyclodextrin, glycerol and xanthan gum in a mass ratio of 1:1:1.

[0072] Example 6

[0073] A pharmaceutical composition for treating eczema-related skin diseases, the pharmaceutical composition being prepared from the following Chinese medicinal raw materials: Dictamni root bark, Angelica sinensis, Isatis indigotica leaf, Hedyotis diffusa, Sophora flavescens, Forsythia suspensa, Hibiscus mutabilis leaf, Chrysanthemum indica, raw licorice, scorched Gardenia jasminoides, Bupleurum chinense, and Magnolia flos, wherein the ingredients include 25g of Dictamni root bark, 15g of Angelica sinensis, 15g of Isatis indigotica leaf, 20g of Hedyotis diffusa, 15g of Sophora flavescens, 8g of Forsythia suspensa, 15g of Hibiscus mutabilis leaf, 6g of Chrysanthemum indica, 4g of raw licorice, 18g of scorched Gardenia jasminoides, 20g of Bupleurum chinense, and 10g of Magnolia flos;

[0074] Among them, the mass ratio of Hedyotis diffusa, Sophora flavescens, Forsythia suspensa, and Hibiscus mutabilis leaves is 20:15:8:15.

[0075] The preparation method of the pharmaceutical composition comprises the following steps:

[0076] S1. According to the recipe, weigh the raw materials, mix them, grind them, pass them through a 300-mesh sieve, add 1000 mL of water, and boil them at 80°C for 3 h. Collect the decoction, filter it, and concentrate the filtrate to 100 mL;

[0077] S2. Add 15 g of pharmaceutical excipients to the obtained concentrate and mix well to obtain the pharmaceutical composition;

[0078] The pharmaceutical excipients are obtained by mixing cyclodextrin, glycerol and xanthan gum in a mass ratio of 1:1:1.

[0079] Example 7

[0080] A pharmaceutical composition for treating eczema-related skin diseases, the pharmaceutical composition being prepared from the following Chinese medicinal raw materials: Dictamni root bark, Chinese angelica, Isatis indigotica leaf, Hedyotis diffusa, Sophora flavescens, Forsythia suspensa, Hibiscus mutabilis leaf, Chrysanthemum indica, raw licorice, scorched Gardenia jasminoides, Bupleurum chinense, and Magnolia flos, wherein the ingredients include 25g of Dictamni root bark, 15g of Chinese angelica, 15g of Isatis indigotica leaf, 20g of Hedyotis diffusa, 15g of Sophora flavescens, 8g of Forsythia suspensa, 15g of Hibiscus mutabilis leaf, 6g of Chrysanthemum indica, 4g of raw licorice, 15g of scorched Gardenia jasminoides, 15g of Bupleurum chinense, and 8g of Magnolia flos;

[0081] Among them, the mass ratio of Hedyotis diffusa, Sophora flavescens, Forsythia suspensa, and Hibiscus mutabilis leaves is 20:15:8:15.

[0082] The preparation method of the pharmaceutical composition comprises the following steps:

[0083] S1. According to the recipe, weigh the raw materials, mix them, grind them, pass them through a 300-mesh sieve, add 1000 mL of water, and boil them at 80°C for 3 h. Collect the decoction, filter it, and concentrate the filtrate to 100 mL;

[0084] S2. Add 15 g of pharmaceutical excipients to the obtained concentrate and mix well to obtain the pharmaceutical composition;

[0085] Among them, the pharmaceutical excipients are obtained by mixing cyclodextrin, glycerol and xanthan gum in a mass ratio of 1:1:1.

[0086] In order to verify the performance of the pharmaceutical composition provided by the present invention, the applicant set up comparative examples 1-4, wherein:

[0087] Comparative Example 1

[0088] A pharmaceutical composition for treating eczema-related skin diseases, the pharmaceutical composition being prepared from the following Chinese medicinal raw materials: Dictamni root bark, Chinese angelica, Isatis indigotica leaf, Hedyotis diffusa, Sophora flavescens, Forsythia suspensa, Hibiscus mutabilis leaf, Chrysanthemum indicum, and raw licorice, wherein: Dictamni root bark 20g, Chinese angelica 12g, Isatis indigotica leaf 5g, Hedyotis diffusa 10g, Sophora flavescens 5g, Forsythia suspensa 8g, Hibiscus mutabilis leaf 10g, Chrysanthemum indicum, and raw licorice 2g;

[0089] Among them, the mass ratio of Hedyotis diffusa, Sophora flavescens, Forsythia suspensa, and Hibiscus mutabilis leaves is 10:5:8:10;

[0090] The preparation method of the pharmaceutical composition comprises the following steps:

[0091] S1. According to the recipe, weigh the raw materials, mix them, grind them, pass them through a 300-mesh sieve, add 1000 mL of water, and boil them at 80°C for 3 h. Collect the decoction, filter it, and concentrate the filtrate to 100 mL;

[0092] S2. Add 15 g of pharmaceutical excipients to the obtained concentrate and mix well to obtain the pharmaceutical composition;

[0093] The pharmaceutical excipients are obtained by mixing cyclodextrin, glycerol and xanthan gum in a mass ratio of 1:1:1.

[0094] Comparative Example 2

[0095] A pharmaceutical composition for treating eczema-related skin diseases, the pharmaceutical composition being prepared from the following Chinese medicinal raw materials: Dictamni root bark, Chinese angelica, Isatis indigotica leaf, Hedyotis diffusa, Sophora flavescens, Forsythia suspensa, Hibiscus mutabilis leaf, Chrysanthemum indica, raw licorice, charred Gardenia jasminoides, and Magnolia flos, wherein the ingredients include 25g of Dictamni root bark, 15g of Chinese angelica, 15g of Isatis indigotica leaf, 20g of Hedyotis diffusa, 15g of Sophora flavescens, 8g of Forsythia suspensa, 15g of Hibiscus mutabilis leaf, 6g of Chrysanthemum indica, 4g of raw licorice, 22g of charred Gardenia jasminoides, and 5g of Magnolia flos;

[0096] Among them, the mass ratio of Hedyotis diffusa, Sophora flavescens, Forsythia suspensa, and Hibiscus mutabilis leaves is 20:15:8:15.

[0097] The preparation method of the pharmaceutical composition comprises the following steps:

[0098] S1. According to the recipe, weigh the raw materials, mix them, grind them, pass them through a 300-mesh sieve, add 1000 mL of water, and boil them at 80°C for 3 h. Collect the decoction, filter it, and concentrate the filtrate to 100 mL;

[0099] S2. Add 15 g of pharmaceutical excipients to the obtained concentrate and mix well to obtain the pharmaceutical composition;

[0100] The pharmaceutical excipients are obtained by mixing cyclodextrin, glycerol and xanthan gum in a mass ratio of 1:1:1.

[0101] Comparative Example 3

[0102] A pharmaceutical composition for treating eczema-related skin diseases, the pharmaceutical composition being prepared from the following Chinese medicinal raw materials: Dictamni root bark, Angelica sinensis, Isatis indigotica leaf, Hedyotis diffusa, Sophora flavescens, Forsythia suspensa, Hibiscus mutabilis leaf, Chrysanthemum indica, raw licorice, scorched Gardenia jasminoides, Bupleurum chinense, and Magnolia flos, wherein the ingredients include 25g of Dictamni root bark, 15g of Angelica sinensis, 15g of Isatis indigotica leaf, 20g of Hedyotis diffusa, 15g of Sophora flavescens, 8g of Forsythia suspensa, 15g of Hibiscus mutabilis leaf, 6g of Chrysanthemum indica, 4g of raw licorice, 10g of Bupleurum chinense, and 5g of Magnolia flos;

[0103] Among them, the mass ratio of Hedyotis diffusa, Sophora flavescens, Forsythia suspensa, and Hibiscus mutabilis leaves is 20:15:8:15.

[0104] The preparation method of the pharmaceutical composition comprises the following steps:

[0105] S1. According to the recipe, weigh the raw materials, mix them, grind them, pass them through a 300-mesh sieve, add 1000 mL of water, and boil them at 80°C for 3 h. Collect the decoction, filter it, and concentrate the filtrate to 100 mL;

[0106] S2. Add 15 g of pharmaceutical excipients to the obtained concentrate and mix well to obtain the pharmaceutical composition;

[0107] The pharmaceutical excipients are obtained by mixing cyclodextrin, glycerol and xanthan gum in a mass ratio of 1:1:1.

[0108] Comparative Example 4

[0109] A pharmaceutical composition for treating eczema-related skin diseases, the pharmaceutical composition being prepared from the following Chinese medicinal raw materials: Dictamni root bark, Chinese angelica, Isatis indigotica leaf, Hedyotis diffusa, Sophora flavescens, Forsythia suspensa, Hibiscus mutabilis leaf, Chrysanthemum indica, raw licorice, charred Gardenia jasminoides, Bupleurum chinense, and Magnolia flos, wherein the ingredients include 25g of Dictamni root bark, 15g of Chinese angelica, 15g of Isatis indigotica leaf, 20g of Hedyotis diffusa, 15g of Sophora flavescens, 8g of Forsythia suspensa, 15g of Hibiscus mutabilis leaf, 6g of Chrysanthemum indica, 4g of raw licorice, 12g of charred Gardenia jasminoides, and 10g of Bupleurum chinense;

[0110] Among them, the mass ratio of Hedyotis diffusa, Sophora flavescens, Forsythia suspensa, and Hibiscus mutabilis leaves is 20:15:8:15.

[0111] The preparation method of the pharmaceutical composition comprises the following steps:

[0112] S1. According to the recipe, weigh the raw materials, mix them, grind them, pass them through a 300-mesh sieve, add 1000 mL of water, and boil them at 80°C for 3 h. Collect the decoction, filter it, and concentrate the filtrate to 100 mL;

[0113] S2. Add 15 g of pharmaceutical excipients to the obtained concentrate and mix well to obtain the pharmaceutical composition;

[0114] The pharmaceutical excipients are obtained by mixing cyclodextrin, glycerol and xanthan gum in a mass ratio of 1:1:1.

[0115] The main properties of the pharmaceutical compositions of Examples 1-7 and Comparative Examples 1-4 were tested respectively, and the following result parameters were obtained:

[0116] 140 SD male rats (purchased from Liaoning Changsheng Biotechnology Co., Ltd.) weighing 180-220 g were randomly selected and, after one week of adaptive feeding, randomly divided into 14 groups, 10 rats in each group, namely, the drug administration group (Examples 1-7, comparative examples 1-4, positive group (tacrolimus ointment, purchased from Sichuan Mingxin Pharmaceutical Co., Ltd.)), the model group, and the blank group.

[0117] First, mark two areas on the back of each rat, one with an area of ​​approximately 0.5 cm × 0.5 cm and the other with an area of ​​approximately 1 cm × 1 cm, with a spacing of 2 cm; use scissors to cut off long hair and shave it clean with a scraper; then apply 7% 2,4-dinitrochlorophenylacetone solution (2,4-dinitrochlorobenzene, CAS number: 97-00-7, purchased from Anno Aromatic Amine Chemicals Co., Ltd.) to the shaved area for sensitization; one week later, apply 0.1% 2,4-dinitrochlorophenylacetone solution to the other depilated area, and stimulate once a week for a total of four weeks; when erythema, papules, scabs, and a little exudation appear on the back lesions of the rats, and some lesions show epidermal exfoliation and scaling, the acute and subacute eczema models of rats are successfully established.

[0118] The depilatory area was smeared with the pharmaceutical composition of Examples 1-7 and Comparative Examples 1-4 (3 times / d, 3g / time); the positive group was smeared with tacrolimus ointment (3 times / d, 3g / time) for one week, and the model group and blank group were not treated; after the last administration, the animals were sacrificed and the skin of the inflamed area and the healthy skin of the corresponding side were cut, and 1cm×1cm of skin was taken respectively, and the body weight was weighed and recorded. The difference between the inflamed skin mass and the healthy skin mass was used to represent the skin swelling. After one week, the skin lesions were recorded and scored. The skin allergic reaction scoring standard was: 0 points for those with no obvious lesions, 1 point for those with mild redness and swelling, 2 points for those with redness and swelling but no papules, 3 points for those with moderate redness and swelling, scabs, no ulceration, and lichenification, and 4 points for those with severe redness and swelling and lichenification papules and ulcers. At the same time, the average value of the skin reaction score of each group was calculated to determine the skin allergic reaction. In addition, blood was collected from the apex of the rats one week later to detect the content of cytokines IL-2 and IL-4 in the serum.

[0119] The data were expressed as mean ± standard deviation. Multiple groups were compared using one-way analysis of variance (ANOVA). Post hoc comparisons were performed using LSD. P < 0.05 indicated statistical significance. The specific results are shown in Tables 1 and 2.

[0120] Table 1:

[0121] Skin swelling / g Inhibition rate / % score Example 1 <![CDATA[0.0656±0.03 a ]]> 35.6 <![CDATA[0.81±0.45 a ]]> Example 2 <![CDATA[0.0572±0.01 a ]]> 39.8 <![CDATA[0.78±0.21 a ]]> Example 3 <![CDATA[0.0604±0.02 a ]]> 38.2 <![CDATA[0.79±0.34 b ]]> Example 4 <![CDATA[0.0571±0.01 b ]]> 40.6 <![CDATA[0.71±0.16 c ]]> Example 5 <![CDATA[0.0426±0.03 a ]]> 43.8 <![CDATA[0.60±0.22 c ]]> Example 6 <![CDATA[0.0405±0.01 c ]]> 44.4 <![CDATA[0.57±0.12 a ]]> Example 7 <![CDATA[0.0359±0.02 d ]]> 45.9 <![CDATA[0.49±0.27 d ]]> Comparative Example 1 <![CDATA[0.0884±0.02 a ]]> 30.8 <![CDATA[0.94±0.27 b ]]> Comparative Example 2 <![CDATA[0.0506±0.01 a ]]> 42.6 <![CDATA[0.68±0.13 b ]]> Comparative Example 3 <![CDATA[0.0523±0.02 c ]]> 41.3 <![CDATA[0.65±0.22 a ]]> Comparative Example 4 <![CDATA[0.0516±0.01 d ]]> 42.0 <![CDATA[0.66±0.18 a ]]> Positive group <![CDATA[0.0821±0.05 a ]]> 25.7 <![CDATA[1.53±0.01 b ]]> Model Group <![CDATA[0.0965±0.01 A ]]> 0.00 <![CDATA[2.75±0.18 B ]]> Blank group 0.0105±0.02 / 0.00

[0122] Table 2:

[0123] IL-2 (pg / mL) IL-4 (pg / mL) Example 1 <![CDATA[0.73±0.10 a ]]> <![CDATA[2.83±0.23 b ]]> Example 2 <![CDATA[0.72±0.11 a ]]> <![CDATA[2.75±0.20 b ]]> Example 3 <![CDATA[0.70±0.16 a ]]> <![CDATA[2.69±0.30 a ]]> Example 4 <![CDATA[0.68±0.07 a ]]> <![CDATA[2.58±0.24 a ]]> Example 5 <![CDATA[0.60±0.17 b ]]> <![CDATA[2.47±0.19 a ]]> Example 6 <![CDATA[0.59±0.14 b ]]> <![CDATA[2.42±0.21 a ]]> Example 7 <![CDATA[0.56±0.09 b ]]> <![CDATA[2.33±0.30 a ]]> Comparative Example 1 <![CDATA[0.78±0.12 b ]]> <![CDATA[3.03±0.16 b ]]> Comparative Example 2 <![CDATA[0.64±0.07 c ]]> <![CDATA[2.54±0.21 b ]]> Comparative Example 3 <![CDATA[0.62±0.09 c ]]> <![CDATA[2.51±0.09 c ]]> Comparative Example 4 <![CDATA[0.66±0.12 d ]]> <![CDATA[2.55±0.14 a ]]> Positive group <![CDATA[0.68±0.13 a ]]> <![CDATA[2.63±0.23 a ]]> Model Group <![CDATA[0.96±0.23 A ]]> <![CDATA[3.14±0.15 A ]]> Blank group 0.53±0.08 2.26±0.31

[0124] Note: Lowercase letters indicate statistical significance between each drug-treated group and the model group, a: P < 0.0001; b: P < 0.001; c: P < 0.01; d: P < 0.05; capital letters indicate statistical differences between the model group and the blank control group, A: P < 0.0001; B: P < 0.001.

[0125] As shown in Tables 1 and 2, compared with the blank group, the skin swelling of the rats in the model group was significant, indicating that the model was successfully established. Compared with the blank group and the positive group, Examples 1-7 and Comparative Examples 1-4 had a significant effect of inhibiting skin swelling. Further comparing Examples 1-4 with Comparative Example 1, the pharmaceutical compositions obtained in Examples 1-4 significantly alleviated the skin swelling of rats and had a good effect of inhibiting eczema, indicating that controlling the mass ratio of Hedyotis diffusa, Sophora flavescens, Forsythia suspensa, and Hibiscus mutabilis leaves is beneficial to improving the efficacy of the drug. Furthermore, comparing Examples 5-7 with Comparative Examples 2-4, it was found that the addition of scorched Gardenia jasminoides, Bupleurum chinense, and Magnolia flos floridulae helped to enhance the efficacy of the drug, and the combined effect of the three was more conducive to the pharmaceutical composition playing a role in treating eczema.

[0126] Compared with the blank group, the IL-2 and IL-4 levels in the serum of the rats in the model group were significantly increased; compared with the model group, the IL-2 and IL-4 levels in the serum of the rats in Examples 1-7, Comparative Examples 1-4 and the positive group were significantly reduced, which fully demonstrated that the pharmaceutical composition of the present invention has a significant therapeutic effect on the treatment of eczema-like skin diseases.

[0127] This specific embodiment is merely an explanation of the present invention and is not intended to limit the present invention. After reading this specification, those skilled in the art may make non-creative modifications to this embodiment as needed. However, as long as such modifications are within the scope of the claims of the present invention, they are protected by patent law.

Claims

1. A pharmaceutical composition for treating eczema-like skin diseases, characterized in that: The pharmaceutical composition is prepared from the following raw materials in parts by weight: 20-30 parts of Dictamnus cortex, 12-25 parts of Angelica sinensis, 5-18 parts of Isatis indigotica, 10-30 parts of Hedyotis diffusa, 5-15 parts of Sophora flavescens, 5-20 parts of Forsythia suspensa, 10-20 parts of Hibiscus mutabilis leaves, 1-10 parts of Chrysanthemum indicum, 2-6 parts of raw Licorice root, 12-18 parts of Gardenia jasminoides, 10-20 parts of Bupleurum chinense, and 5-10 parts of Magnolia officinalis. The mass ratio of Hedyotis diffusa, Sophora flavescens, Forsythia suspensa and Hibiscus mutabilis leaves is 20-30:10-15:8-10:10-15.

2. The pharmaceutical composition for treating eczema-like skin diseases according to claim 1, characterized in that: The pharmaceutical composition is prepared from the following raw materials in parts by weight: 25 parts of Dictamnus cortex, 15 parts of Angelica sinensis, 15 parts of Isatis indigotica, 20 parts of Hedyotis diffusa, 15 parts of Sophora flavescens, 8 parts of Forsythia suspensa, 15 parts of Hibiscus mutabilis leaves, 6 parts of Chrysanthemum indicum, 4 parts of raw Licorice root, 15 parts of Scorched Gardenia jasminoides, 15 parts of Bupleurum chinense, and 8 parts of Magnolia flos.

3. A method for preparing a pharmaceutical composition for treating eczema-like skin diseases according to any one of claims 1 to 2, characterized in that: The following steps are involved: Weigh the raw materials according to the formula, mix, grind, add water and boil, collect the decoction, filter and concentrate the filtrate; Add pharmaceutical excipients to the obtained concentrate and mix them evenly to obtain the pharmaceutical composition.

4. The method for preparing the pharmaceutical composition for treating eczema-like skin diseases according to claim 3, wherein: The pharmaceutical excipient is at least one of cyclodextrin, vaseline, glycerin, gelatin and xanthan gum.