Traditional Chinese medicine composition for treating dermatitis

Abstract

The invention relates to a traditional Chinese medicine composition for treating dermatitis. The traditional Chinese medicine composition is prepared from 10-50 parts by weight of purslane, 1-40 parts by weight of cortex dictamni, 1-30 parts by weight of radix sophorae flavescentis, 1-30 parts by weight of cortex fraxini, 1-30 parts by weight of herba houttuyniae, 1-30 parts by weight of rhizoma smilacis glabrae, 1-30 parts by weight of fructus kochiae, 1-30 parts by weight of herba artemisiae scopariae, 1-30 parts by weight of fructus mume and 1-20 parts by weight of cortex phellodendri. The traditional Chinese medicine composition can treat both symptoms and root causes of acute and subacute-stage damp-heat skin accumulation type dermatitis, can treat both symptoms and root causes through internal and external regulation, has few adverse reactions, is simple in preparation process operation, and is suitable for industrial production.

Description

Technical Field

[0001] The present invention relates to the field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating dermatitis. Background Art

[0002] Dermatitis is a general term for skin inflammatory disorders caused by various internal and external infectious or non-infectious factors. It is not an independent disease. Its etiology and clinical manifestations are complex and diverse, and it recurs frequently, making clinical treatment rather difficult. Specific types of dermatitis include more than 20 diseases such as contact dermatitis, atopic dermatitis, neurodermatitis, irritant dermatitis, etc. Clinically, a specific dermatitis is often defined as a certain dermatitis according to the etiology, the site of onset, or other clinical features. For example, the one caused by contact with a certain substance is called contact dermatitis, and the one caused by taking internal medications is called drug dermatitis, etc.

[0003] Clinically, the main manifestations of damp-heat accumulating in the skin type of dermatitis are erythema, blisters, exudation, erosive skin lesions, accompanied by symptoms such as self-conscious burning, itching, stabbing pain, a sense of tightness, red tongue, thin yellow tongue coating, and taut and slippery pulse. Currently, for the treatment of damp-heat accumulating in the skin type of dermatitis, antihistamine drugs are mainly taken orally, and glucocorticoids are taken internally and externally. However, the recurrence rate of the western medicine treatment plan is high, and the side effects are obvious. For example, antihistamine drugs are prone to adverse reactions such as drowsiness, mental fatigue, headache, blurred vision, and gastrointestinal discomfort. In addition, there are also many side effects of external medications. In particular, external hormone drugs may cause skin allergies, weight gain, excessive hair growth and other adverse conditions.

[0004] Currently, there are few reports on traditional Chinese medicines that can effectively treat dermatitis. Therefore, there is still an urgent need to develop a traditional Chinese medicine with significant clinical efficacy for dermatitis patients, especially those with damp-heat accumulating in the skin type of dermatitis. Summary of the Invention

[0005] To solve the above technical problems, the present invention includes the following aspects:

[0006] The first aspect of the present invention provides a traditional Chinese medicine composition for treating dermatitis, which is made from purslane, cortex dictamni, kuh-seng root, cortex fraxini, houttuynia cordata, glabrous greenbrier rhizome, fructuskochiae, capillaris, smoked plum and cortex phellodendri.

[0007] Preferably, the traditional Chinese medicine composition is made from 10 - 50 parts by weight of purslane, 1 - 40 parts by weight of cortex dictamni, 1 - 30 parts by weight of kuh-seng root, 1 - 30 parts by weight of cortex fraxini, 1 - 30 parts by weight of houttuynia cordata, 1 - 30 parts by weight of glabrous greenbrier rhizome, 1 - 30 parts by weight of fructuskochiae, 1 - 30 parts by weight of capillaris, 1 - 30 parts by weight of smoked plum and 1 - 20 parts by weight of cortex phellodendri.

[0008] More preferably, the traditional Chinese medicine composition is prepared from 20-40 parts by weight of purslane, 10-30 parts by weight of cortex dictamni, 5-25 parts by weight of sophora flavescens, 5-25 parts by weight of cortex fraxini, 5-25 parts by weight of houttuynia cordata, 5-25 parts by weight of glabrous greenbrier rhizome, 5-25 parts by weight of fructuskochiae, 5-25 parts by weight of virgate wormwood, 5-25 parts by weight of smoked plum and 1-20 parts by weight of phellodendron bark.

[0009] Further preferably, the traditional Chinese medicine composition is prepared from 25-35 parts by weight of purslane, 15-25 parts by weight of cortex dictamni, 10-20 parts by weight of sophora flavescens, 10-20 parts by weight of cortex fraxini, 10-20 parts by weight of houttuynia cordata, 10-20 parts by weight of glabrous greenbrier rhizome, 10-20 parts by weight of fructuskochiae, 10-20 parts by weight of virgate wormwood, 10-20 parts by weight of smoked plum and 5-15 parts by weight of phellodendron bark.

[0010] Most preferably, the traditional Chinese medicine composition is prepared from 30 parts by weight of purslane, 20 parts by weight of cortex dictamni, 15 parts by weight of sophora flavescens, 15 parts by weight of cortex fraxini, 15 parts by weight of houttuynia cordata, 15 parts by weight of glabrous greenbrier rhizome, 15 parts by weight of fructuskochiae, 15 parts by weight of virgate wormwood, 15 parts by weight of smoked plum and 10 parts by weight of phellodendron bark.

[0011] Preferably, the traditional Chinese medicine composition further comprises pharmaceutically acceptable excipients.

[0012] Preferably, the traditional Chinese medicine composition is an oral preparation or an external preparation.

[0013] Preferably, the dosage form of the traditional Chinese medicine composition is tablets, capsules, granules, tinctures, decoctions, lotions, gels, ointments, patches.

[0014] More preferably, the dosage form of the traditional Chinese medicine composition is decoction or lotion.

[0015] Preferably, the preparation method of the traditional Chinese medicine composition comprises the following steps: weighing the prescribed amounts of purslane, cortex dictamni, sophora flavescens, cortex fraxini, houttuynia cordata, glabrous greenbrier rhizome, fructuskochiae, virgate wormwood, smoked plum and phellodendron bark, mixing and pulverizing, adding 4-8 times the total weight of the medicinal materials of purified water, boiling and then turning to low heat for decocting for 30-60 minutes, filtering and concentrating the traditional Chinese medicine filtrate to 1-2 times the total weight of the initially added Chinese medicinal materials, thus obtaining.

[0016] Preferably, ⑥ times the total weight of the medicinal materials of purified water is added in the preparation method.

[0017] Preferably, after boiling, it is turned to low heat for decocting for 45 minutes in the preparation method.

[0018] Preferably, the traditional Chinese medicine filtrate is concentrated to the same weight as the total weight of the initially added Chinese medicinal materials in the preparation method.

[0019] Preferably, the dermatitis is acute dermatitis or chronic dermatitis. More preferably, the dermatitis is acute dermatitis.

[0020] Preferably, the dermatitis is contact dermatitis, atopic dermatitis, neurodermatitis or irritant dermatitis.

[0021] Preferably, the dermatitis is dermatitis of damp-heat accumulation type.

[0022] The second aspect of the present invention provides a preparation method of the above-mentioned traditional Chinese medicine composition, and the method comprises the following steps: weighing the prescription amounts of purslane, cortex dictamni, kuh-seng root, cortex fraxini, houttuynia cordata, coix seed, fructuskochiae, capillaris, smoked plum and cortex phellodendri, mixing and pulverizing them, adding purified water 4 - 8 times the total weight of the medicinal materials, boiling and then turning to low heat for decocting for 30 - 60 minutes, filtering and concentrating the traditional Chinese medicine filtrate to 1 - 2 times the total weight of the initially added traditional Chinese medicinal materials, thus obtaining.

[0023] Preferably, 6 times the total weight of the medicinal materials of purified water is added in the preparation method.

[0024] Preferably, after boiling, it is turned to low heat for decocting for 45 minutes in the preparation method.

[0025] Preferably, the traditional Chinese medicine filtrate is concentrated to be the same as the total weight of the initially added traditional Chinese medicinal materials in the preparation method.

[0026] The third aspect of the present invention provides the application of the above-mentioned traditional Chinese medicine composition in the preparation of a drug for treating dermatitis.

[0027] Preferably, the dermatitis is acute dermatitis or chronic dermatitis. More preferably, the dermatitis is acute dermatitis.

[0028] Preferably, the dermatitis is contact dermatitis, atopic dermatitis, neurodermatitis or irritant dermatitis.

[0029] Preferably, the dermatitis is dermatitis of damp-heat accumulation type.

[0030] The fourth aspect of the present invention provides the application of the above-mentioned traditional Chinese medicine composition in the preparation of a drug for reducing the content levels of IL-33 and / or 5-HT in plasma.

[0031] The common pharmacological effects of the traditional Chinese medicine raw materials selected in the present invention are as follows:

[0032] Purslane: sour and cold, clearing heat and detoxifying, cooling blood and stopping dysentery, used as the monarch drug in large dosage to enhance the power of detoxifying and promoting diuresis, especially suitable for damp-heat dysentery and sores. Purslane has anti-inflammatory, antibacterial, antioxidant, analgesic and antipruritic, and wound healing promoting effects, and its antibacterial components can inhibit the pathogenic microorganisms on the skin surface and reduce the occurrence of infections.

[0033] Dictamnus dasycarpus Turcz.: Bitter and cold in nature, clearing heat and drying dampness, dispelling wind and relieving itching, mainly treating skin itching such as eczema and urticaria. Dictamnus dasycarpus Turcz. has the effects of anti - inflammation and immune regulation, antibacterial and antifungal, antioxidant and anti - allergy, and promoting skin barrier repair.

[0034] Sophora flavescens Ait.: Bitter and cold in nature, clearing heat and drying dampness, killing parasites and relieving itching, mainly treating damp - heat in the skin and lower energizer. Sophora flavescens Ait. has the effects of clearing heat, removing dampness, and relieving itching. The main chemical components of Sophora flavescens Ait. include alkaloids, flavonoids, xanthones, quinones, etc., and it has the effects of antibacterial and anti - inflammatory, anti - tumor, and immune regulation.

[0035] Fraxinus rhynchophylla Hance: Bitter, astringent and cold in nature, clearing heat and drying dampness, astringing and stopping dysentery. The coumarin components in Fraxinus rhynchophylla Hance have antibacterial and anti - inflammatory effects, can inhibit pathogenic microorganisms on the skin surface, and reduce the occurrence of infections.

[0036] Houttuynia cordata Thunb.: Pungent and slightly cold in nature, clearing heat and detoxifying, inducing diuresis for treating stranguria, targeting lung heat, urinary tract infections and skin carbuncles. Houttuynia cordata Thunb. has the effects of antibacterial, anti - inflammatory, antiviral, antioxidant, and immune regulation.

[0037] Smilax glabra Roxb.: Sweet, light and flat in nature, detoxifying and removing dampness, dredging the joints, good at treating damp - toxic sores, syphilis and damp - heat stranguria. Smilax glabra Roxb. has the effects of removing dampness, detoxifying, and dredging the joints, and is used for damp - heat stranguria, leukorrhea, carbuncles, scrofula, scabies, syphilis and limb spasm and bone pain caused by mercury poisoning.

[0038] Kochia scoparia (L.) Schrad.: Bitter, pungent and cold in nature, inducing diuresis for treating stranguria, dispelling wind and relieving itching. Kochia scoparia (L.) Schrad. has anti - inflammatory effects, anti - allergy and immune regulation, antibacterial and antifungal, antioxidant, diuretic and detoxifying effects.

[0039] Artemisia capillaris Thunb.: Bitter, pungent and slightly cold in nature, clearing and promoting damp - heat, subsiding jaundice, targeting damp - heat in the liver and gallbladder or jaundice. Artemisia capillaris Thunb. has the effects of clearing heat and promoting damp - heat, promoting bile flow and subsiding jaundice. Clinically, it is mainly used for treating jaundice with scanty urine, damp - warm in summer and dampness, itchy wet sores, and treating diseases such as malaria, hepatitis, cholelithiasis, cholecystitis, liver cancer, etc.

[0040] Fructus Mume: Sour, astringent and flat in nature, astringing the lung and intestine, promoting the production of body fluid and expelling roundworms, assisting in preventing the damage of yin by bitter and cold drugs, and also treating chronic diarrhea and dysentery.

[0041] Phellodendron amurense Rupr.: Bitter and cold in nature, attributing to the kidney and bladder meridians, clearing heat and drying dampness, purging fire and detoxifying, especially good at clearing damp - heat in the lower energizer. Phellodendron amurense Rupr. can significantly relieve the swelling, exudation and itching of dermatitis patients, and reduce the release of inflammatory mediators.

[0042] The technical effects produced by the present invention:

[0043] Based on a large number of screening tests, through optimizing the components and ratios of traditional Chinese medicines, an oral and topical traditional Chinese medicine preparation with remarkable curative effect for treating dermatitis is obtained. This preparation treats both internally and externally, and for acute and sub-acute dermatitis of the type with damp-heat accumulating in the skin, it not only treats the symptoms but also addresses the root cause, coordinating internal and external conditions, treating both symptoms and root cause, and having a remarkable curative effect. The traditional Chinese medicine composition of the present invention has definite curative effect, is safe and reliable, has few adverse reactions, and the preparation process is simple to operate, being suitable for industrial production. Detailed implementation manners

[0044] Example 1

[0045] Weigh 30 g of Portulaca oleracea, 20 g of Dictamnus dasycarpus Turcz., 15 g of Sophora flavescens, 15 g of Cortex Fraxini, 15 g of Houttuynia cordata, 15 g of Smilax glabra, 15 g of Kochia scoparia, 15 g of Artemisia capillaris, 15 g of Prunus mume, and 10 g of Phellodendron amurense. After mixing, pulverize them, add 1 L of pure water, boil and then turn to low heat and decoct for 45 minutes. After filtration, concentrate the traditional Chinese medicine filtrate to 200 mL to obtain the traditional Chinese medicine decoction 1 of the present invention.

[0046] Example 2

[0047] Weigh 15 g of Portulaca oleracea, 20 g of Dictamnus dasycarpus Turcz., 30 g of Sophora flavescens, 15 g of Cortex Fraxini, 15 g of Houttuynia cordata, 15 g of Smilax glabra, 15 g of Kochia scoparia, 15 g of Artemisia capillaris, 15 g of Prunus mume, and 10 g of Phellodendron amurense. After mixing, pulverize them, add 1 L of pure water, boil and then turn to low heat and decoct for 45 minutes. After filtration, concentrate the traditional Chinese medicine filtrate to 200 mL to obtain the traditional Chinese medicine decoction 2 of the present invention.

[0048] Example 3

[0049] Weigh 15 g of Portulaca oleracea, 20 g of Dictamnus dasycarpus Turcz., 15 g of Sophora flavescens, 30 g of Cortex Fraxini, 15 g of Houttuynia cordata, 15 g of Smilax glabra, 15 g of Kochia scoparia, 15 g of Artemisia capillaris, 15 g of Prunus mume, and 10 g of Phellodendron amurense. After mixing, pulverize them, add 1 L of pure water, boil and then turn to low heat and decoct for 45 minutes. After filtration, concentrate the traditional Chinese medicine filtrate to 200 mL to obtain the traditional Chinese medicine decoction 3 of the present invention.

[0050] Example 4

[0051] Weigh 15 g of Portulaca oleracea, 20 g of Dictamnus dasycarpus Turcz., 15 g of Sophora flavescens, 15 g of Cortex Fraxini, 30 g of Houttuynia cordata, 15 g of Smilax glabra, 15 g of Kochia scoparia, 15 g of Artemisia capillaris, 15 g of Prunus mume, and 10 g of Phellodendron amurense. After mixing, pulverize them, add 1 L of pure water, boil and then turn to low heat and decoct for 45 minutes. After filtration, concentrate the traditional Chinese medicine filtrate to 200 mL to obtain the traditional Chinese medicine decoction 4 of the present invention.

[0052] Comparative Example 1 (Artemisia capillaris replaced with Polygonum cuspidatum)

[0053] Weigh 30 g of Portulaca oleracea, 20 g of Dictamnus dasycarpus, 15 g of Sophora flavescens, 15 g of Cortex Fraxini, 15 g of Houttuynia cordata, 15 g of Smilax glabra, 15 g of Kochia scoparia, 15 g of Polygonum cuspidatum, 15 g of Prunus mume, and 10 g of Phellodendron amurense. Mix and pulverize them, add 1 L of purified water, bring to a boil, then turn to low heat and decoct for 45 minutes. After filtration, concentrate the traditional Chinese medicine filtrate to 200 mL to obtain the traditional Chinese medicine decoction of Comparative Example 1.

[0054] Comparative Example 2 (Dictamnus dasycarpus replaced with Cnidium monnieri)

[0055] Weigh 30 g of Portulaca oleracea, 20 g of Cnidium monnieri, 15 g of Sophora flavescens, 15 g of Cortex Fraxini, 15 g of Houttuynia cordata, 15 g of Smilax glabra, 15 g of Kochia scoparia, 15 g of Artemisia capillaris, 15 g of Prunus mume, and 10 g of Phellodendron amurense. Mix and pulverize them, add 1 L of purified water, bring to a boil, then turn to low heat and decoct for 45 minutes. After filtration, concentrate the traditional Chinese medicine filtrate to 200 mL to obtain the traditional Chinese medicine decoction of Comparative Example 2.

[0056] Experimental Example 1. Efficacy of the traditional Chinese medicine composition of the present invention on a mouse model of atopic dermatitis

[0057] [[ID=!2]]1. Test method

[0058] Take 80 male BALB / c mice at 8 weeks of age and randomly divide them into 8 groups, namely the blank group, the model group, the groups of Examples 1-4 of the present invention, and the groups of Comparative Examples 1-2, with 10 mice in each group. On the 0th day, depilate the back of the mice (2 cm × 3 cm). Except for the blank group, on the 1st day, apply 1% dinitrochlorobenzene (DNCB) solution (150 μL on the back and 20 μL on the right ear) to the back of the mice in the remaining experimental groups for primary sensitization for 2 consecutive days, with a 4-day interval. Subsequently, on the 7th, 9th, 11th, and 13th days, apply 0.2% DNCB solution to the back and right ear of the mice to sensitize the skin to maintain the AD-like inflammatory reaction. If the back skin of the mice shows edema, erythema, crusting accompanied by scratching in the early stage, and then dark erythema and scales appear on the back skin of the mice, it can be regarded as successful modeling. The mice in the groups of Examples 1-4 and the groups of Comparative Examples 1-2 were intragastrically administered the decoctions prepared in Examples 1-4 of the present invention and Comparative Examples 1-2 respectively at a dose of 25 ml / kg body weight from the 3rd day to the 15th day of the experiment. The model group and the blank group were intragastrically administered the same dose of normal saline once a day. 24 hours after the last administration, the mice were anesthetized and blood was collected by vein. After centrifugation of the blood, take the supernatant and operate strictly according to the instructions of the IL-33 and 5-HT kits to measure the contents of IL-33 and 5-HT in the plasma of the mice in each experimental group.

[0059] 2. Test results

[0060] The results of the levels of IL-33 in the serum of the mice and 5-HT in the skin lesions after the mice in each experimental group were given different traditional Chinese medicine compositions are shown in Table 1 below.

[0061] Table 1 Comparison of the contents of IL-33 and 5-HT in the plasma of the mice in each experimental group

[0062] Group IL-33 (pg / mL) 5-HT (pg / mL) Blank group 117.48±5.61 109.25±8.21 Model group 168.29±11.37 277.12±13.92 Example 1 group 121.37±6.28 154.90±9.25 Example 2 group 130.51±7.62 183.47±10.67 Example 3 group 133.25±7.91 189.32±10.03 Example 4 group 137.41±8.25 193.47±11.25 Comparative example 1 group 150.29±9.45 220.35±11.94 Comparative example 2 group 148.42±8.97 215.92±12.05

[0063] When the skin is scratched due to itching, keratinocytes release IL-33, which directly downregulates the expression of claudin-1 and actin, thereby aggravating dermatitis and reducing the skin barrier function. 5-HT is an important monoamine neurotransmitter that participates in the regulation of various physiological activities and behavioral functions of the body and is also an important histamine-independent pruritus mediator. As can be seen from Table 1 above, compared with the blank group, the contents of IL-33 and 5-HT in the serum of mice in the model group were significantly increased (with statistical differences). Compared with the model group and Comparative Examples 1-2 groups, the contents of IL-33 and 5-HT in the serum of mice in Examples 1-4 groups of the present invention were significantly decreased (both with statistical differences). The above test results confirm that the traditional Chinese medicine composition of the present invention can significantly reduce the contents of IL-33 and 5-HT in the serum of mice and inhibit the inflammatory reaction of mouse skin tissue. Its mechanism of action may be related to the regulation of the levels of IL-33 and 5-HT, and it is expected that the traditional Chinese medicine composition of the present invention has a significant curative effect in the clinical treatment of dermatitis. Surprisingly, when the total weight of the traditional Chinese medicinal materials is the same, the reduction amplitude of the contents of IL-33 and 5-HT in the serum of mice after administration of the traditional Chinese medicine in Example 1 is significantly greater than that of other example groups, producing an unexpectedly excellent therapeutic effect.

[0064] Test Example 2. Clinical Efficacy Test of the Traditional Chinese Medicine Composition of the Present Invention in Treating Dermatitis

[0065] 1. Test method

[0066] 1.1. Research subjects

[0067] Combined with the four diagnostic information and the characteristics of syndrome differentiation of the patients, clinical patients were screened for inclusion. After the patients signed the informed consent, they were included in the study, and a total of 20 clinical patients were included.

[0068] 1.2. Inclusion and exclusion criteria

[0069] Inclusion criteria: ① Meeting the clinical diagnostic criteria; ② Aged over 5 years and less than 70 years; ③ Voluntarily participating in this study, giving informed consent and signing the informed consent form.

[0070] Exclusion criteria: ① Those with a sensitive constitution and those who informed that they are allergic to the test drugs; ② Those with drug addiction or alcoholism; patients with mental diseases; ③ Those with malignant tumors, severe heart diseases, blood system diseases, cerebrovascular accidents, severe trauma or major surgery; ④ Those who participated in another clinical trial within three months; ⑤ Pregnant or women planning pregnancy and lactating women; ⑥ Those who the researcher judged as not suitable for participating in this study.

[0071] 1.3. Diagnostic criteria

[0072] Western medicine diagnosis criteria: It is acceptable if it meets the criteria for atopic dermatitis, contact dermatitis, seborrheic dermatitis, and stasis dermatitis.

[0073] Traditional Chinese medicine diagnosis criteria: For dermatitis of the damp-heat accumulating in the skin type, referring to the description of the traditional Chinese medicine syndrome criteria for "eczema" in "Integrated Traditional Chinese and Western Medicine Dermatology and Venereology" edited by Chen Deyu: There are 2 or more main symptoms and 2 or more secondary symptoms. Main symptoms: ① Erythema, papules; ② Vesicles, papulovesicles, etc.; ③ Pruritus, scratch marks; ④ Long course of disease, prone to recurrence.

[0074] 1.4, Treatment plan

[0075] The enrolled patients adopted the treatment plan of taking traditional Chinese medicine orally and washing externally. Among them, the traditional Chinese medicine taken orally was 1 dose of the traditional Chinese medicine prepared in Example 1, 200 mL of the medicinal liquid, and 100 mL was taken 0.5 hour after breakfast and dinner every day. The traditional Chinese medicine for external use was 1 dose of the traditional Chinese medicine prepared in Example 1, 200 mL of the medicinal liquid, diluted with water to 400 mL, and applied externally to the skin lesions for 20 minutes each time or bathed at 39 °C for 10 minutes every day. 4 weeks was 1 course of treatment, and the curative effect was judged after 1 course of treatment.

[0076] 1.5, Curative effect evaluation criteria

[0077] According to the Eczema area and severity index (EASI) scoring criteria, the EASI scores of the enrolled patients were evaluated before and after treatment; by asking the patients to score according to the "Dermatology Life Quality Index Questionnaire", the Dermatology Life Quality Index (DLQI) scores before and after treatment were statistically analyzed.

[0078] 2. Test results

[0079] The EASI and DLQI scores of the enrolled patients before treatment and 4 weeks after treatment are shown in Table 2.

[0080] Table 2 Scores of the traditional Chinese medicine composition of the present invention in treating dermatitis patients before and after 4 weeks

[0081] Efficacy index Before treatment (X±S) After treatment (X±S) t P EASI score 22.93±7.49 11.20±8.00 9.185 0.000 DLQI score 21.45±3.25 4.14±1.05 6.72 0.000

[0082] As shown in Table 2, through paired t-test, it was found that there were statistically significant differences in the EASI scores and DLQI scores of the enrolled patients before and after treatment (P < 0.05), indicating that the traditional Chinese medicine composition of the present invention can significantly improve the skin lesion symptoms and quality of life of dermatitis patients clinically.

[0083] Test example 3, Clinical cases of the traditional Chinese medicine composition of the present invention in treating dermatitis

[0084] Case 1

[0085] Patient Zhang, male, 34 years old, was initially diagnosed on August 18, 2023.

[0086] Chief complaint: Recurrent erythematous papules with itching in the scrotum, groin and anus for half a year, aggravated for 1 month.

[0087] Current medical history: Six months ago, the patient developed erythema and itching on the scrotum without apparent cause. He ignored the issue, which gradually worsened and spread to the groin and anus. He received multiple external hospital treatments, including oral antihistamines, topical glucocorticoids, and traditional Chinese medicine for clearing heat and dampness, with limited success. In the past month, he has experienced worsening of the lesions, with prominent erythema and oyster-shell-like proliferations on the scrotum, groin, and anus, and severe itching, which has severely impacted his sleep and mental state. He enjoys spicy and greasy foods, frequently drinks alcohol at social events, and suffers from high work pressure, irritability, poor sleep, loose, sticky, and foul-smelling stools. His tongue is red, with thick, long, web-like veins under the tongue, a greasy, yellowish coating, and a rapid, slippery pulse. EASI score: 4.2, DLQI score: 30.

[0088] Western Medicine Diagnosis: Dermatitis. Traditional Chinese Medicine Diagnosis: Eczema. Syndrome: Damp-heat accumulation in the skin. Treatment: Clear heat and dampness, detoxify and relieve itching. Treatment Plan: Take 200 mL of the Chinese herbal decoction prepared in Example 1 of the present invention, one dose daily, divided into two doses, one hour after meals, in the morning and evening.

[0089] Second visit: No new skin lesions were observed, some lesions subsided, and pruritus improved significantly. The patient reported maintaining a light diet during treatment, and his stools gradually became formed. EASI score: 3.2, DLQI score: 18. The tongue was red, with varicose sublingual veins, a thin yellow greasy coating, and a rapid and stringy pulse. The previous prescription was continued for 7 doses, with the same usage instructions.

[0090] Third visit: Skin lesions have improved significantly compared to before, with erythema subsiding and oyster shell lesions essentially subsiding and improving. Localized pigmentation is visible. Appetite is good, bowel movements are regular, EASI score: 1.4, DLQI score: 10. Tongue is red with a thin, greasy yellow coating, and pulse is stringy and rapid. Continue taking the above-mentioned medicine for 7 doses, using the same instructions as before.

[0091] Four examinations: The skin lesions have basically subsided, leaving local pigmentation, and the patient is basically cured.

[0092] Follow-up by telephone 3 months later showed no recurrence.

[0093] Case 2

[0094] The patient, Chen Moumou, female, 74 years old, visited the hospital on January 4, 2024, and the onset of the disease occurred on the winter solstice.

[0095] Chief complaint: erythema, papules and itching on the lower limbs for 2 weeks.

[0096] History of present illness: Two weeks ago, the patient developed erythema, papules and pruritus on the lower extremities without obvious incentive. During that period, the patient visited other hospitals several times. The diagnosis was "eczema". Treatment with topical "Halometasone Ointment" and oral administration of "Cetirizine" was given, but the effect was not satisfactory. In order to seek further diagnosis and treatment, the patient came to our hospital. There were erythema, papules, a small amount of desquamation on both lower extremities, severe pruritus, accompanied by thirst and a preference for drinking, poor appetite, and sticky stools. Urination was normal. The tongue was red and crimson, the coating was white, and the pulse was slippery and rapid. EASI score: 6.

[0097] Past history: The patient had a history of diabetes, denied other major medical histories, denied blood transfusion history, trauma history, and surgical history. The vaccination history was routine. Denied food, drug and other allergic histories.

[0098] Western medicine diagnosis: Dermatitis. Traditional Chinese medicine diagnosis: Damp sores, syndrome of damp-heat accumulating in the skin. Treatment principle: Clear heat and remove dampness, detoxify and relieve itching. Treatment plan: Take 200 mL of the traditional Chinese medicine decoction prepared in Example 1 of the present invention, 1 dose per day, and take it twice after meals 1 hour in the morning and evening.

[0099] Second visit: One week later for a follow-up visit. The skin lesions improved compared with before. EASI score: 3.6. The itching of the local skin lesions improved. The thirst and preference for cold drinks were reduced compared with before. The appetite recovered. The sticky stools improved. Urination was normal. The tongue was red, and the coating was white. The pulse was slippery. Continue to follow the original prescription.

[0100] Third visit: Basically cured.

[0101] Case 3

[0102] Patient Huang, female, 21 years old, visited on November 14, 2022.

[0103] Chief complaint: Repeated erythema, papules and pruritus all over the body for 3 months, aggravated for 1 week.

[0104] History of present illness: Three months ago, the patient developed scattered erythema, papules and pruritus all over the body without obvious incentive, especially on the face. It recurred repeatedly. During that period, the patient visited other hospitals several times. The diagnosis was "atopic dermatitis". Antihistamines and topical corticosteroid ointments were used to apply to the body, and non-steroidal ointments (specifics unknown) were used to apply to the face. The symptoms were sometimes mild and sometimes severe, and were prone to recurrence after stopping the drugs. One week ago, the above symptoms were aggravated without obvious incentive, especially the skin rash on the face was significantly aggravated. So the patient came to our hospital for treatment today. When visiting, the whole body skin was dry, with scattered erythema and papules, especially on the face. The erythema and papules were scattered all over the face, accompanied by severe pruritus, dry stools, less urine, red and crimson tongue, and string-taut and rapid pulse. EASI score: 3.7, DLQI score: 7.

[0105] Past history: The patient had a generally good constitution, denied major medical histories, and denied infectious disease histories, etc.

[0106] Western medicine diagnosis: Atopic dermatitis. Traditional Chinese medicine diagnosis: Four-bend wind, syndrome type: Damp-heat accumulating in the skin. Treatment principle: Clear heat and remove dampness, detoxify and relieve itching. Treatment plan: Take 200 mL of the traditional Chinese medicine decoction prepared in Example 1 of the present invention, 1 dose per day, and take it in two divided doses 1 hour after breakfast and dinner. Apply Bofuyan repair cream topically on the face, once in the morning and once in the evening.

[0107] Second visit: One week later for follow-up. The skin rashes all over the body have basically improved, and the skin rashes on the face have significantly reduced compared to before. No new skin lesions are seen. EASI score: 2.5. Continue with the original prescription for 7 doses, and the usage method is the same as before.

[0108] Third visit: One week later, the skin lesions are basically completely cleared.

[0109] Case 4

[0110] Patient, female, 48 years old, visited on August 5, 2024.

[0111] Chief complaint: Facial erythema, papules accompanied by itching for 4 days. EASI score: 0.4 points.

[0112] Present illness history: The patient developed facial erythema, papules accompanied by itching 4 days after using a new skin care product. At that time, it was not taken seriously. Today, it has worsened, so she came to see a doctor. There are a large number of scattered erythema and papules on the face. The skin lesions at the affected area are rough, the skin lines are deepened, it feels hot to the touch. The skin lesions are more severe around the eyes and the corners of the mouth. She feels severe itching and stabbing pain, accompanied by difficulty falling asleep. Her appetite is okay. The tongue is red, the tongue coating is yellow and greasy, and the pulse is string-like and slippery.

[0113] Past medical history: The patient has a generally good constitution, shows manifestations of allergic rhinitis, denies major medical history, denies blood transfusion history, trauma history, surgical history. The vaccination history is routine. Denies food, drug and other allergies.

[0114] Western medicine diagnosis: Allergic dermatitis. Traditional Chinese medicine diagnosis: Eczema, damp-heat accumulating in the skin type. Treatment principle: Clear heat and remove dampness, detoxify and relieve itching. Treatment plan: Take 200 mL of the traditional Chinese medicine decoction prepared in Example 1 of the present invention, 1 dose per day, and take it in two divided doses 1 hour after breakfast and dinner.

[0115] Second visit: Three days later for follow-up. The color of the facial erythema has become lighter compared to before, but it itches around the eyes and mouth. EASI score: 0.2. She is not thirsty, her appetite and bowel movements are okay. The tongue is red, the tongue coating is greasy, and the pulse is slippery and string-like. Continue with the previous prescription for 3 doses, and the usage method is the same as before.

[0116] Third visit: Three days later for follow-up, cured.

[0117] Case 5

[0118] Patient Zhang, female, 28 years old, visited on November 5, 2023.

[0119] Chief complaint: Erythema, papules accompanied by exudation and itching on both upper extremities for 3 days.

[0120] Present history: Three days ago, after consuming spicy seafood, the patient developed dense erythema and papules the size of millet grains on both forearms. Some of them merged into patches, accompanied by yellow exudate, severe itching, and increased exudate after scratching. The patient had a dry mouth and bitter taste, yellow urine, and sticky stools. EASI score: 4.4 points.

[0121] Past history: The patient generally had good physical constitution, with manifestations of allergic rhinitis. Denied a history of major diseases, blood transfusion history, trauma history, and surgical history. The vaccination history was in accordance with the routine. Denied food, drug, and other allergies.

[0122] Western medicine diagnosis: Allergic dermatitis. Traditional Chinese medicine diagnosis: Damp eczema, type of damp-heat accumulating in the skin. Treatment principle: Clear heat and remove dampness, detoxify and relieve itching. Treatment plan: Take 200 mL of the traditional Chinese medicine decoction prepared in Example 1 of the present invention, 1 dose per day, and take it twice after meals 1 hour in the morning and evening.

[0123] Second visit: Three days later for a follow-up visit, the color of the erythema became lighter than before. EASI score: 1.2. The patient was not thirsty, had normal appetite and bowel movements. The tongue was red, the tongue coating was greasy, and the pulse was slippery and string-like. Continue with the previous prescription for 3 doses, and the usage method is the same as before.

[0124] Third visit: Three days later for a follow-up visit, the patient was cured.

[0125] Although the specific implementation modes of the present invention have been described, those skilled in the art should recognize that various changes and modifications can be made to the present invention without departing from the scope or spirit of the present invention. Therefore, the present invention is intended to cover all such changes and modifications that fall within the scope of the appended claims and their equivalents.

Claims

1. A traditional Chinese medicine composition for treating dermatitis, characterized in that, The traditional Chinese medicine composition is prepared from purslane, dictamnus cortex, sophora flavescens, ash bark, houttuynia cordata, coix seed, fructuskochiae, virgate wormwood, smoked plum and phellodendron amurense.

2. The traditional Chinese medicine composition according to claim 1, wherein The traditional Chinese medicine composition is prepared from 10 - 50 parts by weight of purslane, 1 - 40 parts by weight of dictamnus cortex, 1 - 30 parts by weight of sophora flavescens, 1 - 30 parts by weight of ash bark, 1 - 30 parts by weight of houttuynia cordata, 1 - 30 parts by weight of coix seed, 1 - 30 parts by weight of fructuskochiae, 1 - 30 parts by weight of virgate wormwood, 1 - 30 parts by weight of smoked plum and 1 - 20 parts by weight of phellodendron amurense.

3. The traditional Chinese medicine composition according to claim 2, characterized in that, The traditional Chinese medicine composition is prepared from 20 - 40 parts by weight of purslane, 10 - 30 parts by weight of dictamnus cortex, 5 - 25 parts by weight of sophora flavescens, 5 - 25 parts by weight of ash bark, 5 - 25 parts by weight of houttuynia cordata, 5 - 25 parts by weight of coix seed, 5 - 25 parts by weight of fructuskochiae, 5 - 25 parts by weight of virgate wormwood, 5 - 25 parts by weight of smoked plum and 1 - 20 parts by weight of phellodendron amurense.

4. The traditional Chinese medicine composition according to claim 3, wherein, The traditional Chinese medicine composition is prepared from 25 - 35 parts by weight of purslane, 15 - 25 parts by weight of dictamnus cortex, 10 - 20 parts by weight of sophora flavescens, 10 - 20 parts by weight of ash bark, 10 - 20 parts by weight of houttuynia cordata, 10 - 20 parts by weight of coix seed, 10 - 20 parts by weight of fructuskochiae, 10 - 20 parts by weight of virgate wormwood, 10 - 20 parts by weight of smoked plum and 5 - 15 parts by weight of phellodendron amurense.

5. The traditional Chinese medicine composition according to claim 4, wherein The traditional Chinese medicine composition is prepared from 30 parts by weight of purslane, 20 parts by weight of dictamnus cortex, 15 parts by weight of sophora flavescens, 15 parts by weight of ash bark, 15 parts by weight of houttuynia cordata, 15 parts by weight of coix seed, 15 parts by weight of fructuskochiae, 15 parts by weight of virgate wormwood, 15 parts by weight of smoked plum and 10 parts by weight of phellodendron amurense.

6. The traditional Chinese medicine composition according to any one of claims 1-5, characterized in that, The traditional Chinese medicine composition further comprises pharmaceutically acceptable excipients.

7. The traditional Chinese medicine composition according to any one of claims 1-5, characterized in that The traditional Chinese medicine composition is an oral preparation or an external preparation.

8. The traditional Chinese medicine composition according to claim 7, characterized in that The dosage form of the traditional Chinese medicine composition is tablets, capsules, granules, tinctures, decoctions, lotions, gels, ointments, patches.

9. The preparation method of the traditional Chinese medicine composition according to any one of claims 1-8, characterized in that, The method comprises the following steps: weighing the prescribed amounts of purslane, dictamnus cortex, sophora flavescens, ash bark, houttuynia cordata, coix seed, fructuskochiae, virgate wormwood, smoked plum and phellodendron amurense, mixing and pulverizing them, adding 4 - 8 times the total weight of the medicinal materials of purified water, boiling and then turning to a low heat and decocting for 30 - 60 minutes, filtering and concentrating the traditional Chinese medicine filtrate to 1 - 2 times the total weight of the initially added Chinese medicinal materials, thus obtaining.

10. Use of the traditional Chinese medicine composition according to any one of claims 1 - 8 in the preparation of a drug for treating dermatitis.