External-use powder for treating acute eczema and preparation method thereof

Abstract

The present invention relates to an external-use powder for treating acute eczema and a preparation method thereof. The external-use powder comprises 96-136 parts by weight of calamine, 1-3 parts by weight of Poria extract, 8-10 parts by weight of Dictamni cortex extract, 3-5 parts by weight of Forsythia suspensa extract, 7-9 parts by weight of Paeonia suffruticosa extract, 5-7 parts by weight of Cnidium monnieri extract, and 0.6-0.85 parts by weight of borneol. The external-use powder of the present invention has a significant therapeutic effect on acute eczema, can significantly inhibit the degree of auricular swelling in an acute eczema mouse model, and improve pathological changes such as epidermal and dermal edema and inflammatory cell infiltration in the mouse auricle tissue; can effectively reduce the toxicity and dosage of calamine, and can improve the safety of calamine; can effectively overcome the adverse aspects and contradictory problems of borneol in regulating allergen-specific immunoglobulin E and leukotriene B4, and can simultaneously reduce serum IgE and LTB4 levels.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to an external-use powder for treating acute eczema and a preparation method thereof. Background Art

[0002] Eczema is an inflammation of the superficial dermis and epidermis caused by various factors. Depending on the severity of the condition, it is categorized as acute, chronic, and subacute. Once patients develop acute eczema, they are susceptible to infection by external microorganisms such as viruses and bacteria, which can further develop into chronic eczema. Therefore, finding effective treatments for acute eczema is crucial for its management. Acute eczema often presents as dense, multi-faceted papules and vesicles on the skin, accompanied by intense itching, burning, and exudation. It is prone to recurring attacks and is difficult to heal. Histopathology often reveals varying degrees of structural damage to the epidermis and dermis, with blurred stratification, degeneration, necrosis, hyperkeratosis, thickening of the stratum spinosum, edema of the surrounding tissues, and diffuse infiltration of inflammatory cells. The etiology of eczema is complex, and its pathogenesis is likely closely linked to inflammatory responses, immune imbalance, epidermal barrier dysfunction, and abnormal expression of signaling proteins in the itch sensory pathway. Excessive release of allergen-specific immunoglobulin E (IgE), a type of immunoglobulin, can contribute to allergic diseases and inflammation. Leukotriene B4 (LTB4) is a proinflammatory mediator that can induce the recruitment and activation of neutrophils, monocytes, and eosinophils. Measuring the expression of antibodies against these two proteins can be an important tool for assessing the occurrence of eczema and the efficacy of medications.

[0003] According to statistics, the prevalence of eczema in industrialized countries has doubled to tripled over the past 30 years, affecting 15% to 30% of children and 2% to 10% of adults worldwide, severely impacting patients' physical and mental health, as well as their work and daily lives. Traditional Chinese medicine (TCM) has a long history of treating acute eczema, offering advantages such as excellent efficacy, low recurrence rates, and minimal adverse reactions. TCM therapies, particularly external treatments with Chinese herbal medicine, are widely used in the treatment of acute eczema, offering excellent efficacy and a high safety profile, suitable for all populations, including children and pregnant women. Common external treatments include topical application, wet compresses, fumigation and soaking, and acupuncture and bloodletting. The main therapeutic principles of TCM external treatments for acute eczema are to "clear heat and dampness, dispel wind and relieve itching, and cool the blood and detoxify." Calamine is a commonly used TCM herb with a sweet and neutral nature. It enters the liver and spleen meridians, possessing antiseptic, astringent, and protective properties. It can be used to detoxify, improve eyesight, remove cataracts, absorb dampness, relieve itching, and heal sores. However, Baidu Encyclopedia shows that because it contains harmful trace elements such as lead and cadmium, accidental ingestion can cause strong irritation and corrosiveness to the gastrointestinal tract; and the zinc oxide it contains can denature proteins and damage organs when it enters the blood, with kidney damage being the most obvious.

[0004] A review of existing invention patents for eczema treatments revealed that many only tested swelling, without examining indicators such as inflammation and immunity, leading to flawed evaluation methods. Another example is the high dosage of calamine used in Chinese patent CN102872158B, which raises safety concerns. Summary of the Invention

[0005] Aiming at the deficiencies of existing treatment options, the present invention proposes an acute eczema external-use powder with no toxic or side effects, which can reduce swelling, resist inflammation and regulate immune function.

[0006] The technical solution adopted to achieve the technical purpose of the present invention is:

[0007] Disclosed is an external-use powder for treating acute eczema. The external-use powder comprises 96-136 parts by weight of calamine, 1-3 parts by weight of a polyporus extract, 8-10 parts by weight of a Dictamni cortex extract, 3-5 parts by weight of a Forsythia suspensa extract, 7-9 parts by weight of a Paeonia suffruticosa extract, 5-7 parts by weight of a Cnidium monnieri extract, and 0.6-0.85 parts by weight of borneol.

[0008] Preferably, the external-use powder is composed of 116 parts by weight of calamine, 2 parts by weight of Poria extract, 9 parts by weight of Dictamni cortex extract, 4 parts by weight of Forsythia suspensa extract, 8 parts by weight of Paeonia suffruticosa extract, 6 parts by weight of Cnidium monnieri extract and 0.7 parts by weight of borneol.

[0009] The invention discloses an application of an external-use powder in preparing a functional product for treating acute eczema. The external-use powder comprises 96-136 parts by weight of calamine, 1-3 parts by weight of a polyporus extract, 8-10 parts by weight of a difficile cortex extract, 3-5 parts by weight of a forsythia extract, 7-9 parts by weight of a peony bark extract, 5-7 parts by weight of a cnidium monnieri extract, and 0.6-0.85 parts by weight of borneol. The functional product comprises a medicine, a health product, or a daily chemical product.

[0010] Preferably, the external powder is used in the preparation of a functional product for acute eczema, wherein the external powder is composed of 116 parts by weight of calamine, 2 parts by weight of Poria extract, 9 parts by weight of Dictamni extract, 4 parts by weight of Forsythia extract, 8 parts by weight of Paeonia suffruticosa extract, 6 parts by weight of Cnidium monnieri extract and 0.7 parts by weight of borneol.

[0011] A method for preparing an external-use powder comprises the following steps:

[0012] (1) Grinding of medicinal materials: Grind the medicinal materials of Polyporus umbellatus, Dictamni root bark, Forsythia suspensa, Paeonia suffruticosa root bark, and Cnidium monnieri respectively to obtain coarse powder of each medicinal material;

[0013] (2) Ethanol extraction: The crude powder of each medicinal material obtained in step (1) was subjected to condensation reflux extraction twice with 60% ethanol solution (10 times the weight of the medicinal material) as solvent, each time for 1 hour, and filtered while hot to obtain Poria extract, Dictamni extract, Forsythia extract, Paeonia suffruticosa extract and Cnidium monnieri extract respectively;

[0014] (3) Drying under reduced pressure: The extracts obtained in step (2) are concentrated under reduced pressure until there is no ethanol taste, thereby obtaining a suspension of Polyporus umbellatus, a suspension of Dictamni cortex, a suspension of Forsythia suspensa, a suspension of Paeonia suffruticosa and a suspension of Cnidium monnieri; the suspension of Polyporus umbellatus, a suspension of Dictamni cortex, a suspension of Forsythia suspensa, a suspension of Paeonia suffruticosa and a suspension of Cnidium monnieri are mixed according to 1-3 parts by weight of Polyporus umbellatus extract, 8-10 parts by weight of Dictamni cortex extract, 3-5 parts by weight of Forsythia suspensa extract, 7-9 parts by weight of Paeonia suffruticosa extract and 5-7 parts by weight of Cnidium monnieri extract, and dried under reduced pressure to obtain an extract;

[0015] (4) Drying and pulverizing: Add 4 times the weight of the extract to the extract obtained in step (3), mix well, dry under reduced pressure, and then pulverize. Finally, add 0.025 times the weight of the extract in borneol, mix well, pulverize, and pass through a No. 6 sieve. The 60% ethanol solution used in the experiment is by volume.

[0016] The preferred preparation method of traditional Chinese medicine powder is that the Poria suspension, Dictamni root suspension, Forsythia suspensa suspension, Paeonia suffruticosa suspension and Cnidium monnieri suspension can also be Polyporus umbellatus extract, Dictamni root extract, Forsythia suspensa extract, Paeonia suffruticosa extract and Cnidium monnieri extract.

[0017] This patent combines calamine with six traditional Chinese medicines, including Poria cocos, Dictamni root bark, Paeonia suffruticosa, Forsythia suspensa, Cnidium monnieri, and Borneol, to reduce the dosage of calamine and avoid the risk of accidental ingestion. It also studies its optimal composition through prescription decomposition, blood index testing, and pathological section staining, achieving good technical results.

[0018] The pharmacological effects of the 7 Chinese medicinal pieces of the present invention are as follows:

[0019] 1. Calamine: A carbonate mineral from the calcite family, smithsonite primarily contains zinc carbonate (ZnCO3). After mining, it is washed, sun-dried, and free of debris. It is sweet and neutral in nature, and enters the liver and spleen meridians. It is used to treat persistent ulcers, pus-filled ulcers, and itchy eczema.

[0020] 2. Poria: It is the dried sclerotium of the Polyporus umbellatus (Pers.) Fries fungus of the Polyporaceae family. It is also known as wild poria, pig feces poria, and pig dung fungus. It is sweet, light, and flat in nature. It mainly promotes diuresis and eliminates dampness. Traditional Chinese medicine believes that removing dampness can treat eczema.

[0021] 3. Dictamnus dasycarpus Turcz.: It is the dried root bark of the Rutaceae plant Dictamnus dasycarpus Turcz. It is bitter and cold in nature, can clear away heat and dampness, dispel wind and detoxify, and is often used for damp-heat sores and eczema.

[0022] 4. Cnidium monnieri: Also known as wild fennel, wild carrot, snake rice, and snake chestnut, it is the dried mature fruit of Cnidium monnieri (L.) Cuss., a plant of the Apiaceae family. It is pungent, bitter, and warm in nature and flavor; it has the effects of drying dampness and dispelling wind, killing insects and relieving itching, and warming the kidneys and strengthening yang.

[0023] 5. Peony bark: Also known as moutan bark, pink moutan bark, and wood peony root, it is the dried root bark of the Rutaceae plant Paeonia suffruticosa Andr. It is bitter, pungent, and slightly cold in nature. It clears heat and cools the blood, promotes blood circulation, and removes blood stasis. It is used to treat heat invading the blood, carbuncles, sores, and ulcers.

[0024] 6. Forsythia: It is the dried fruit of Forsythia suspensa (Thunb.) Vahl., a plant of the Oleaceae family. It is bitter and slightly cold in nature, and can clear away heat, detoxify, and dispel wind-heat.

[0025] 7. Borneol: also known as synthetic borneol, borneol, and wormwood powder, it is a colorless, transparent or white translucent flaky, crisp crystal. It is pungent, bitter, and cool in nature. It can invigorate the mind, clear away heat and relieve pain, and promote transdermal absorption of drugs.

[0026] The beneficial effects of the present invention are:

[0027] 1. The forsythia extract, peony bark extract, etc. of the present invention can effectively reduce the toxicity of calamine, especially the nephrotoxicity, and can improve the safety of calamine. At the same time, the forsythia extract, peony bark extract, etc. are compatible with calamine, which can reduce the dosage of calamine and further improve the safety of medication.

[0028] 2. The external-use powder of the present invention has a significant therapeutic effect on acute eczema, can significantly inhibit the swelling of the auricle of the acute eczema mouse model, and improve pathological changes such as edema of the epidermis and dermis of the mouse auricle tissue and inflammatory cell infiltration.

[0029] 3. The forsythia extract, peony bark extract, etc. of the present invention can effectively overcome the adverse aspects and contradictory problems of borneol in regulating allergen-specific immunoglobulin E (IgE) and leukotriene B4 (LTB4), and achieve the simultaneous reduction of serum IgE levels and LTB4 levels. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Figure 1 This is a pathological section of the right ear of mice in the blank group.

[0031] Figure 2 This is a pathological section of the right ear of mice in the model group.

[0032] Figure 3 This is a pathological section of the right ear of mice in the hydrocortisone group.

[0033] Figure 4 2 is a pathological section of the right ear of mice in Example 1 group.

[0034] Figure 5 This is a pathological section of the right ear of a mouse in comparative example 1.

[0035] Figure 6 This is a pathological section of the right ear of a mouse in comparative example 2.

[0036] Figure 7 This is a pathological section of the right ear of a mouse in comparative example 3.

[0037] Figure 8 This is a pathological section of the right ear of a mouse in comparative example 4.

[0038] Figure 9 This is a pathological section of the right ear of a mouse in comparative example 5.

[0039] Figure 10 This is a pathological section of the right ear of a mouse in comparative example 6. DETAILED DESCRIPTION

[0040] Example 1 Preparation of external-use powder for acute eczema

[0041] (1) Grinding of medicinal materials: Grind the medicinal materials of Polyporus umbellatus, Forsythia suspensa, Dictamni root bark, Paeonia suffruticosa root bark, and Cnidium monnieri respectively to obtain coarse powder of medicinal materials;

[0042] (2) Ethanol extraction: 10 g of the crude powder of the medicinal material obtained in step (1) was subjected to condensation reflux extraction twice using 60% (10 times the weight of the medicinal material) ethanol as solvent, each time for 1 hour, each time for 100 ml, and filtered while hot to obtain the extract;

[0043] (3) Drying under reduced pressure: The extract obtained in step (2) is concentrated under reduced pressure until there is no ethanol smell, thereby obtaining a suspension; the suspensions of several medicinal materials are combined and dried under reduced pressure to obtain an extract.

[0044] (4) Crushing: Add 4 times the weight of calamine powder to the extract obtained in step (3), mix well, add 0.025 times the weight of the extract (0.32 g) of borneol, mix well, grind, and pass through a No. 6 sieve to obtain the product.

[0045] Example 2 Preparation of external-use powder for acute eczema

[0046] (1) Take 0.4g of Poria extract, 1.3g of Forsythia suspensa extract, 3.6g of Dictamni root extract, 3.1g of Paeonia suffruticosa root extract, and 2.2g of Cnidium monnieri extract.

[0047] (2) Add 42.7 g of calamine powder to the extract obtained in step (1), mix well, add 0.27 g of borneol, mix well, grind, and pass through a No. 6 sieve to obtain the extract.

[0048] Example 3 Preparation of external-use powder for acute eczema

[0049] (1) Take 1.3g of Poria extract, 2.2g of Forsythia suspensa extract, 4.4g of Dictamni root extract, 4.0g of Paeonia suffruticosa root extract, and 3.1g of Cnidium monnieri extract.

[0050] (2) Add 60.4 g of calamine powder to the extract obtained in step (1), mix well, add 0.38 g of borneol, mix well, grind, and pass through a No. 6 sieve to obtain the extract.

[0051] Example 4 Preparation of Polyporus umbellatus Extract

[0052] (1) Grinding of medicinal materials: Grind the Polyporus umbellatus medicinal materials to obtain coarse medicinal material powder;

[0053] (2) Ethanol extraction: 10 g of the crude powder of the medicinal material obtained in step (1) was subjected to condensation reflux extraction twice with 60% (10 times the weight of the medicinal material) ethanol as solvent, each time for 1 hour, each time with 100 ml, and filtered while hot to obtain the extract;

[0054] (3) Drying under reduced pressure: The extract obtained in step (2) was concentrated under reduced pressure until there was no ethanol smell, thereby obtaining a suspension; the suspension was dried under reduced pressure to obtain a Poria extract containing 0.9 g.

[0055] Example 5 Preparation of Forsythia suspensa Extract

[0056] (1) Crush the medicinal materials: Crush the medicinal materials of Forsythia suspensa to obtain coarse powder;

[0057] (2) Ethanol extraction: 10 g of the crude powder of the medicinal material obtained in step (1) was subjected to condensation reflux extraction twice with 60% (10 times the weight of the medicinal material) ethanol as solvent, each time for 1 hour, each time with 100 ml, and filtered while hot to obtain the extract;

[0058] (3) Drying under reduced pressure: The extract obtained in step (2) was concentrated under reduced pressure until no ethanol smell was found, thereby obtaining a suspension; the suspension was dried under reduced pressure to obtain 1.8 g of Forsythia suspensa extract.

[0059] Example 6 Preparation of Dictamnus cortex extract

[0060] (1) Grinding of medicinal materials: Grinding the Dictamnus cortex medicinal materials to obtain coarse medicinal material powder;

[0061] (2) Ethanol extraction: 10 g of the crude powder of the medicinal material obtained in step (1) was subjected to condensation reflux extraction twice with 60% (10 times the weight of the medicinal material) ethanol as solvent, each time for 1 hour, each time with 100 ml, and filtered while hot to obtain the extract;

[0062] (3) Drying under reduced pressure: The extract obtained in step (2) was concentrated under reduced pressure until no ethanol smell was found, thereby obtaining a suspension; the suspension was dried under reduced pressure to obtain 4.0 g of Dictamnus cortex extract.

[0063] Example 7 Preparation of Paeonia suffruticosa Andrews Extract

[0064] (1) Grinding of medicinal materials: Grinding the Paeonia suffruticosa root to obtain coarse medicinal material powder;

[0065] (2) Ethanol extraction: 10 g of the crude powder of the medicinal material obtained in step (1) was subjected to condensation reflux extraction twice with 60% (10 times the weight of the medicinal material) ethanol as solvent, each time for 1 hour, each time with 100 ml, and filtered while hot to obtain the extract;

[0066] (3) Drying under reduced pressure: The extract obtained in step (2) was concentrated under reduced pressure until no ethanol smell was found, thereby obtaining a suspension; the suspension was dried under reduced pressure to obtain 3.6 g of Paeonia suffruticosa Andrews extract.

[0067] Example 8 Preparation of Cnidium monnieri Extract

[0068] (1) Grinding of medicinal materials: Grinding the Paeonia suffruticosa root to obtain coarse medicinal material powder;

[0069] (2) Ethanol extraction: 10 g of the crude powder of the medicinal material obtained in step (1) was subjected to condensation reflux extraction twice with 60% (10 times the weight of the medicinal material) ethanol as solvent, each time for 1 hour, each time with 100 ml, and filtered while hot to obtain the extract;

[0070] (3) Drying under reduced pressure: The extract obtained in step (2) was concentrated under reduced pressure until there was no ethanol smell, thereby obtaining a suspension; the suspension was dried under reduced pressure to obtain 2.7 g of Cnidium monnieri extract.

[0071] Comparative Example 1

[0072] (1) Grinding of medicinal materials: Grind the medicinal materials of Polyporus umbellatus, Dictamni root bark, Paeonia suffruticosa root bark and Cnidium monnieri respectively to obtain coarse powder of medicinal materials;

[0073] (2) Ethanol extraction: 10 g of the crude powder of the medicinal material obtained in step (1) was subjected to condensation reflux extraction twice using 60% (10 times the weight of the medicinal material) ethanol as solvent, each time for 1 hour, each time for 100 ml, and filtered while hot to obtain the extract;

[0074] (3) Drying under reduced pressure: The extract obtained in step (2) is concentrated under reduced pressure until there is no ethanol smell, thereby obtaining a suspension; the suspensions of several medicinal materials are combined and dried under reduced pressure to obtain an extract.

[0075] (4) Crushing: Add 4 times the weight of calamine powder to the extract obtained in step (3), mix well, add 0.025 times the weight of the extract (0.28g) borneol, mix well, grind, and pass through a No. 6 sieve to obtain the product.

[0076] Comparative Example 2

[0077] (1) Grinding of medicinal materials: Grind the medicinal materials of Polyporus umbellatus, Dictamnus dasyphylla, Forsythia suspensa, and Cnidium monnieri respectively to obtain coarse powder of medicinal materials;

[0078] (2) Ethanol extraction: 10 g of the crude powder of the medicinal material obtained in step (1) was subjected to condensation reflux extraction twice using 60% (10 times the weight of the medicinal material) ethanol as solvent, each time for 1 hour, each time for 100 ml, and filtered while hot to obtain the extract;

[0079] (3) Drying under reduced pressure: The extract obtained in step (2) is concentrated under reduced pressure until there is no ethanol smell, thereby obtaining a suspension; the suspensions of several medicinal materials are combined and dried under reduced pressure to obtain an extract.

[0080] (4) Crushing: Add 4 times the weight of calamine powder to the extract obtained in step (3), mix well, add 0.025 times the weight of the extract (0.24 g) of borneol, mix well, grind, and pass through a No. 6 sieve to obtain the product.

[0081] Comparative Example 3

[0082] (1) Grinding of medicinal materials: Grind the medicinal materials of Polyporus umbellatus, Paeonia suffruticosa, Forsythia suspensa, and Cnidium monnieri respectively to obtain coarse powder of medicinal materials;

[0083] (2) Ethanol extraction: 10 g of the crude powder of the medicinal material obtained in step (1) was subjected to condensation reflux extraction twice using 60% (10 times the weight of the medicinal material) ethanol as solvent, each time for 1 hour, each time for 100 ml, and filtered while hot to obtain the extract;

[0084] (3) Drying under reduced pressure: The extract obtained in step (2) is concentrated under reduced pressure until there is no ethanol smell, thereby obtaining a suspension; the suspensions of several medicinal materials are combined and dried under reduced pressure to obtain an extract.

[0085] (4) Crushing: Add 4 times the weight of calamine powder to the extract obtained in step (3), mix well, add 0.025 times the weight of the extract (0.23 g) of borneol, mix well, grind, and pass through a No. 6 sieve to obtain the product.

[0086] Comparative Example 4

[0087] (1) Grinding of medicinal materials: Grind the medicinal materials of Polyporus umbellatus, Dictamni root bark, Paeonia suffruticosa root bark and Forsythia suspensa respectively to obtain coarse powder of medicinal materials;

[0088] (2) Ethanol extraction: 10 g of the crude powder of the medicinal material obtained in step (1) was subjected to condensation reflux extraction twice using 60% (10 times the weight of the medicinal material) ethanol as solvent, each time for 1 hour, each time for 100 ml, and filtered while hot to obtain the extract;

[0089] (3) Drying under reduced pressure: The extract obtained in step (2) is concentrated under reduced pressure until there is no ethanol smell, thereby obtaining a suspension; the suspensions of several medicinal materials are combined and dried under reduced pressure to obtain an extract.

[0090] (4) Crushing: Add 4 times the weight of calamine powder to the extract obtained in step (3), mix well, add 0.025 times the weight of the extract (0.26 g) of borneol, mix well, grind, and pass through a No. 6 sieve to obtain the product.

[0091] Comparative Example 5

[0092] (1) Grinding of medicinal materials: Grind the Dictamni root bark, Paeonia suffruticosa root bark, Forsythia suspensa root and Cnidium monnieri fruit respectively to obtain coarse powder of medicinal materials;

[0093] (2) Ethanol extraction: 10 g of the crude powder of the medicinal material obtained in step (1) was subjected to condensation reflux extraction twice using 60% (10 times the weight of the medicinal material) ethanol as solvent, each time for 1 hour, each time for 100 ml, and filtered while hot to obtain the extract;

[0094] (3) Drying under reduced pressure: The extract obtained in step (2) is concentrated under reduced pressure until there is no ethanol smell, thereby obtaining a suspension; the suspensions of several medicinal materials are combined and dried under reduced pressure to obtain an extract.

[0095] (4) Crushing: Add 4 times the weight of calamine powder to the extract obtained in step (3), mix well, add 0.025 times the weight of the extract (0.3 g) of borneol, mix well, grind, and pass through a No. 6 sieve to obtain the product.

[0096] Comparative Example 6

[0097] (1) Grinding of medicinal materials: Grind the medicinal materials of Polyporus umbellatus, Dictamni root bark, Paeonia suffruticosa, Forsythia suspensa, and Cnidium monnieri respectively to obtain coarse powder of medicinal materials;

[0098] (2) Ethanol extraction: 10 g of the crude powder of the medicinal material obtained in step (1) was subjected to condensation reflux extraction twice using 60% (10 times the weight of the medicinal material) ethanol as solvent, each time for 1 hour, each time for 100 ml, and filtered while hot to obtain the extract;

[0099] (3) Drying under reduced pressure: The extract obtained in step (2) is concentrated under reduced pressure until there is no ethanol smell, thereby obtaining a suspension; the suspensions of several medicinal materials are combined and dried under reduced pressure to obtain an extract.

[0100] (4) Pulverization: Add calamine powder in a quantity 4 times the weight of the extract obtained in step (3) (51.6 g) to the extract, mix well and grind, then sieve through sieve No. 6 to obtain the product.

[0101] Example 9 Animal Experiment

[0102] Select 8 SPF-grade Kunming mice, with 4 males and 4 females, purchased from Henan Sk贝斯 Biotechnology Co., Ltd. (License No.: SCXK[Henan]2020-0005), weighing 20 g ± 2 g, and 7 - 8 weeks old. Randomly divide them into a drug administration group (Example 1), a blank control group, a model control group, and a hydrocortisone butyrate group, with 2 mice in each group, 1 male and 1 female.

[0103] One day before the experiment, shave the abdominal hair. On the 1st day, sensitize the abdomen with 100 μL of 5% 2,4-dinitrochlorobenzene acetone solution. On the 7th day, evenly apply 30 μL of 1% 2,4-dinitrochlorobenzene acetone solution to the inner and outer ears of the right ear for excitation, and apply 30 μL of acetone solution to the left ear as a control. On the 9th day, repeat once; on the 11th day, repeat for the second time. Administer the drug to the skin on both sides of the right ear, twice a day, 0.1 - 0.2 g each time, for 7 days. After the drug administration is completed, sacrifice the mice and cut off both ears along the baseline of the ears.

[0104] The scoring method for skin damage of the right ear auricle of mice in each group refers to the "Scoring Method for Eczema Area and Severity Index". The main observation manifestations of eczema degree are edema / papules, erythema, exudation / crusting, exfoliation / scratching, and lichenification. Score the severity of eczema manifestations from 0 to 3 points. 0 points means none (not determined even after careful observation), 1 point means mild (visible only after careful observation), 2 points means moderate (this sign can be seen immediately), 3 points means severe (this sign is very obvious), and 0.5 points can be recorded between the scores of various symptoms. The results are shown in Table 1. Compared with the blank group, the model group showed obvious redness and swelling; the redness and swelling degrees of the auricles of mice in the hydrocortisone butyrate group and Example 1 group were less than those in the model group. The swelling score of the auricles of male mice was lower than that of the female group, so male mice were selected for further experiments.

[0105] Table 1 Skin Damage Scoring Table of the Right Ear Auricle of Mice in Each Group

[0106]

[0107] Example 10 Animal Experiment

[0108] 1. Experimental Method [[ID=Sixty-six SPF-grade male Kunming mice, weighing 20 g ± 2 g and 7 - 8 weeks old, were purchased from Henan Sk贝斯 Biotechnology Co., Ltd. (License No.: SCXK[Henan]2020 - 0005). They were divided into a blank control group, a model control group, a drug administration group (Example 1 group, Comparative Examples 1 - 6 groups), a hydrocortisone butyrate group, and a calamine administration group (calamine fine powder), with 6 mice in each group.

[0110] One day before the experiment, the abdominal hair of the mice was shaved. On the first day, 100 μL of a 5% 2,4-dinitrochlorobenzene acetone olive oil solution was used for abdominal sensitization. On the seventh day, 30 μL of a 1% 2,4-dinitrochlorobenzene acetone olive oil solution was evenly applied to the inner and outer ears of the right ear for excitation, and 30 μL of an acetone olive oil solution was applied to the left ear as a control. On the ninth day, the above operation was repeated once; on the eleventh day, it was repeated a second time. After the model was established, in the drug administration group, the powder was evenly applied to the skin on both the inner and outer sides of the right ear twice a day, about 0.1 g each time, and olive oil was used as an adhesive; in the blank group, an equal amount of olive oil was applied; in the positive drug administration group, hydrocortisone butyrate cream was evenly applied to the ear skin; in the calamine administration group, calamine fine powder was administered to the skin in the same way as the drug administration group. The administration lasted for 7 days. After the administration ended, the mice were sacrificed, and both ears were immediately cut along the baseline of the ears. Two ear round pieces with consistent positions were obtained using a 6 mm puncher. After weighing with an analytical balance, the auricle swelling degree was calculated; their kidneys and livers were taken to calculate the organ index.

[0111] 2. Results

[0112] As shown in Table 1, compared with the blank group, the auricle swelling degree of the mice in the model group was significantly increased, indicating that the model was successfully established; the auricle swelling degrees of the mice in the positive group, the calamine administration group, and the drug administration group were all lower than that in the model group. The effect of the Example 1 group was the best (P < 0.01), and the effects of the Comparative Examples 4 and 5 groups were the second (P < 0.05). There was no significant difference between the calamine administration group and the model group, indicating that the effect of the Example 1 group was better than that of the calamine group.

[0113] The auricle swelling degree of the mice was calculated using the following formula:

[0114] Swelling degree = (weight of the left ear piece - weight of the right ear piece) / weight of the left ear piece × 100%.

[0115] Table 2 Effects of drugs on the auricle tissue swelling degree of eczema mice [[ID=^{19}]]<^{0000250}>

[0116]

[0117] Note: Compared with the blank group,

[0115] ,

[0118] , ,

[0114] , , △△△ , <0^{0000252}>, ,

[0117] ,

[0116] , P < 0.001; compared with the model group, **P < 0.01, *P < 0.05.

[0118] 2.2 There were no significant differences in the liver and kidney indices of the mice in the hydrocortisone group, Example 1 group, and each comparative example group compared with the blank group; however, the kidney indices of the mice in the calamine-administered group were significantly lower than those in the blank group (P < 0.05), indicating that external use of calamine alone has certain nephrotoxicity, and the Chinese medicine formula of the present invention reduces the nephrotoxicity of calamine to a certain extent.

[0119] Table 3 Organ indexes of mice in each group

[0120]

[0121] Note: Compared with the blank group, △ P<0.05.

[0122] 2.3 Pathological results showed that no inflammatory cells were observed in the blank group, and the tissue structure was neatly arranged. The auricle epidermis of the mice in the model group was thickened with a squamous epithelium, and the dermis showed large areas of severe edema, congestion and dilation of blood vessels, diffuse infiltration of neutrophils, and a large number of lymphocytes proliferating. The auricle skin structure of the mice in the positive drug group, Example 1 group, and Comparative Example 6 group was clear, and no inflammatory cells were observed. The auricle epidermis of the mice in Comparative Examples 1 to 3 groups was slightly thickened, the blood vessels in the dermis were congested and dilated, and a small amount of neutrophil infiltration was visible. There were no obvious abnormalities in the auricle skin tissue structure of the mice in Comparative Examples 4 and 5 groups. The edema of the epidermis and intercellular space was reduced, and the edema of the dermis was significantly reduced, but a small number of inflammatory cells, mainly neutrophils and macrophages, were still visible.

[0123] 2.4 Enzyme-linked immunosorbent assay was used to detect serum IgE and LTB4 levels in mice. The results are shown in Table 4. Compared with the model group, the serum IgE levels of mice in the hydrocortisone group, Example 1 group, and Comparative Examples 1 to 6 groups were significantly reduced. Except for Comparative Example 2 group, which had a P < 0.01, the other groups had a P < 0.0001. Compared with the hydrocortisone group, Example 1 group and Comparative Example 5 group showed no significant differences (P < 0.05), while the other groups showed significant differences (P < 0.001). The regulatory effect of hydrocortisone on serum IgE levels was poorer than that of hydrocortisone.

[0124] Serum LTB4 levels in mice treated with hydrocortisone, Example 1, and Comparative Examples 3-6 were significantly different from those in the model group (P < 0.05). Comparative Examples 1 and 2, in which Forsythia suspensa and Paeonia suffruticosa were removed, respectively, showed elevated serum LTB4 levels in mice after administration, with no significant difference compared to the model group. This suggests that Paeonia suffruticosa and Forsythia suspensa possess potent anti-inflammatory properties and play a key role in the topical powder of the present invention. Compared to Example 1, Comparative Examples 3-5, which removed Dictamni Cortex, Cnidium monnieri, and Polyporus umbellatus, respectively, significantly reduced LTB4 levels, but the effect was less pronounced than that observed in Example 1. Comparative Example 6, in which borneol was removed, showed beneficial effects on reducing serum LTB4 levels but not on serum IgE levels. This suggests that borneol's regulatory effects on serum IgE and LTB4 levels in mice are inconsistent and conflicting.

[0125] Table 4 Comparison of IgE and LTB4 levels in serum of mice in each group

[0126]

[0127] Note: Compared with the blank group, △△△△ P < 0.0001, △△△ P<0.001; compared with the model group, ****P<0.0001, ***P<0.001, **P<0.01, *P<0.05.

[0128] The Example 1 group and the Comparative Examples 1 to 6 groups can all play a role in treating acute eczema, among which the auricle swelling inhibition rate, skin pathological sections, and IgE detection results of the Example 1 are all the best, indicating that the Example 1 of the present invention has the best effect.

[0129] The above is only a preferred embodiment of the present invention. It should be pointed out that ordinary technicians in this technical field can make several improvements and supplements without departing from the method of the present invention. These improvements and supplements should also be regarded as the scope of protection of the present invention.

Claims

1. An external-use powder for treating acute eczema, characterized in that: The external powder comprises 96-136 parts by weight of calamine, 1-3 parts by weight of polyporus extract, 8-10 parts by weight of difficile cortex extract, 3-5 parts by weight of forsythia extract, 7-9 parts by weight of peony bark extract, 5-7 parts by weight of cnidium monnieri extract and 0.6-0.85 parts by weight of borneol; the polyporus extract, difficile cortex extract, forsythia extract, peony bark extract and cnidium monnieri extract are respectively extracted twice with 60% ethanol condensation and reflux for 1 hour each time from polyporus coarse powder, difficile cortex coarse powder, forsythia coarse powder, peony bark coarse powder and cnidium monnieri coarse powder, each extract is concentrated under reduced pressure until there is no ethanol taste, and dried under reduced pressure to obtain the extract.

2. The external-use powder according to claim 1, characterized in that The external-use powder consists of 116 parts by weight of calamine, 2 parts by weight of Poria extract, 9 parts by weight of Dictamni cortex extract, 4 parts by weight of Forsythia suspensa extract, 8 parts by weight of Paeonia suffruticosa extract, 6 parts by weight of Cnidium monnieri extract and 0.7 parts by weight of borneol.

3. A use of the external-use powder according to claim 1 in the preparation of a medicament for treating acute eczema, wherein the external-use powder is composed of 96-136 parts by weight of calamine, 1-3 parts by weight of Poria extract, 8-10 parts by weight of Dictamni cortex extract, 3-5 parts by weight of Forsythia suspensa extract, 7-9 parts by weight of Paeonia suffruticosa extract, 5-7 parts by weight of Cnidium monnieri extract and 0.6-0.85 parts by weight of borneol.

4. The use of the external-use powder according to claim 3, characterized in that The external-use powder consists of 116 parts by weight of calamine, 2 parts by weight of Poria extract, 9 parts by weight of Dictamni cortex extract, 4 parts by weight of Forsythia suspensa extract, 8 parts by weight of Paeonia suffruticosa extract, 6 parts by weight of Cnidium monnieri extract and 0.7 parts by weight of borneol.

5. A method for preparing the external-use powder according to claim 1, characterized in that: The steps include: (1) Grinding of medicinal materials: Grind the medicinal materials of Polyporus umbellatus, Dictamni root bark, Forsythia suspensa, Paeonia suffruticosa root bark, and Cnidium monnieri respectively to obtain coarse powder of each medicinal material; (2) Ethanol extraction: The crude powder of each medicinal material obtained in step (1) was subjected to condensation reflux extraction twice with 60% ethanol solution in an amount 10 times the weight of the medicinal material as solvent, each time for 1 hour, and filtered while hot to obtain Poria extract, Dictamni extract, Forsythia extract, Paeonia suffruticosa extract and Cnidium monnieri extract respectively; (3) Drying under reduced pressure: The extracts obtained in step (2) are concentrated under reduced pressure until no ethanol taste is detected, thereby obtaining a suspension of Polyporus umbellatus, a suspension of Dictamni root bark, a suspension of Forsythia suspensa, a suspension of Paeonia suffruticosa root bark, and a suspension of Cnidium monnieri. The mixtures are mixed and dried under reduced pressure to obtain an extract. (4) Drying and crushing: Add 4 times the weight of calamine powder to the extract obtained in step (3), mix well, dry under reduced pressure and crush, and finally add 0.025 times the weight of borneol, mix well and crush, and pass through a No. 6 sieve.

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