Traditional Chinese medicine composition for treating psoriasis as well as preparation method and application thereof

Abstract

The invention provides a traditional Chinese medicine composition for treating psoriasis as well as a preparation method and application thereof, the traditional Chinese medicine composition takes indigo naturalis and lithospermum as a basic formula, camellia oil is supplemented, and Sichuan coptis root, radix sophorae flavescentis and rhizoma zedoariae or different combinations thereof are respectively added in different compatibility; according to the invention, the ground powder and / or the extracted active ingredients are combined according to the mass parts; according to the invention, active ingredients of indigo naturalis, lithospermum erythrorhizon and sophora flavescens are extracted, and compatibility is carried out based on the obtained active ingredients to obtain different ointments and pharmaceutically achievable medicament forms for treating psoriasis. The compound preparation comprises traditional Chinese medicine components and skin protection components for combined use, and the treatment effect is more comprehensive through the combined action of exterior and interior. And the traditional Chinese medicine composition is prepared from all natural components, so that the side effects are low, and hormone dependence is avoided.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicines, and in particular relates to a traditional Chinese medicine composition for treating psoriasis, a preparation method thereof and uses thereof. Background Art

[0002] The skin is the largest organ in the human body. Dermatology is the clinical discipline with the most diseases, with nearly 2,000 diseases currently counted. Dermatological diseases have the highest incidence rate. Data show that about 150 million people in my country suffer from skin diseases every year, and the incidence rate is as high as over 80% in the southern population of my country. In the Yellow River and Yangtze River basins, subtropical areas, the Middle East, Europe, and America, where the temperature is high and humidity, the vast majority of people suffer from psoriasis and itching of varying degrees, and tens of thousands of people suffer from skin diseases. Although skin diseases have regional and seasonal differences, in general, skin diseases are global diseases.

[0003] Psoriasis, commonly known as psoriasis, is an immune-mediated, hereditary, chronic skin disease that manifests itself on the skin or joints or both. Because of its great impact on physical appearance, it can trigger negative reactions from others, increasing the psychological burden of patients with the disease that is difficult to measure. Compared with a range of other chronic diseases, including cancer, myocardial infarction, and congestive heart failure, only depression and chronic lung disease have a greater impact on psychological quality of life than psoriasis. In Europe and North America, the prevalence of psoriasis is about 2%, and the incidence in Asian populations is 0.1%-0.5%. Patients with psoriasis are at increased risk of other chronic and serious health diseases, including psoriatic arthritis, metabolic syndrome or components of the syndrome, cardiovascular disease, and other diseases such as anxiety and depression, non-alcoholic fatty liver disease, Crohn's disease, and lymphoma, of which the most serious complication is psoriatic arthritis. At present, the treatment of psoriasis is mostly for a single pathogenic factor or mechanism, which has certain limitations in efficacy and adverse reactions, and is far from achieving the ideal therapeutic effect. Summary of the invention

[0004] In order to overcome the defects and shortcomings of the prior art, the present invention provides a Chinese medicine composition for treating psoriasis and its preparation method and use In order to achieve the above-mentioned purpose of the invention, according to the first aspect of the technical solution of the present invention, a traditional Chinese medicine composition for treating psoriasis is provided, which is made of the following traditional Chinese medicine raw materials in parts by mass: 10-20 parts of Indigo Naturalis, 3-8 parts of Lithospermum Officinale, 8-12 parts of Coptis Chinensis, 3-8 parts of Curcuma Atractylodes, and 200-300 parts of camellia oil; or 200-300 parts of Indigo Naturalis, 80-120 parts of Lithospermum Officinale powder, 80-120 parts of Sophora Flavescentis powder, and 1000-1500 parts of camellia oil; or 10-80 parts of Indigo Naturalis, 8-70 parts of Lithospermum Officinale, and 12-80 parts of Sophora Flavescentis powder.

[0005] Preferably, the traditional Chinese medicine composition for treating psoriasis is made from the following traditional Chinese medicine raw materials by weight: 15 parts of indigo naturalis, 5 parts of lithospermum root, 10 parts of coptis root, 5 parts of zedoary turmeric, and 250 parts of camellia oil.

[0006] Preferably, the traditional Chinese medicine composition for treating psoriasis is made from the following traditional Chinese medicine raw materials by weight: 250 parts of indigo naturalis, 100 parts of lithospermum root, 100 parts of sophora flavescens root, and 1250 parts of camellia oil.

[0007] Preferably, the traditional Chinese medicine composition for treating psoriasis is made from the following traditional Chinese medicine raw materials by weight: 16 - 56 parts of indigo naturalis, 11 - 50 parts of lithospermum root, and 16 - 50 parts of sophora flavescens root.

[0008] Further, among the traditional Chinese medicine raw materials, indigo naturalis is used as indigo naturalis powder, lithospermum root is used as lithospermum root oil, coptis root is used as coptis root powder, or zedoary turmeric is used as zedoary turmeric oil, or sophora flavescens root is used as sophora flavescens root powder.

[0009] More preferably, among the traditional Chinese medicine raw materials, there are 15 parts of indigo naturalis powder, 5 parts of lithospermum root oil, 10 parts of coptis root powder, 5 parts of zedoary turmeric oil, and 250 parts of camellia oil.

[0010] More preferably, among the traditional Chinese medicine raw materials, there are 250 parts of indigo naturalis powder, 100 parts of lithospermum root powder, 100 parts of sophora flavescens root powder, and the effective components in the supernatant are obtained by centrifugation after soaking in 1250 parts of camellia oil to obtain an extract.

[0011] More preferably, there are 16 - 50 parts of indigo naturalis powder, 10 - 50 parts of lithospermum root powder, 10 - 50 parts of sophora flavescens root powder. Ethanol is added at a liquid - to - solid ratio of 15 mL / g and refluxed at 80°C for 2 h, extracted 3 times repeatedly, the supernatant is combined, ethanol is recovered, and an extract is obtained by concentration and vacuum drying.

[0012] Further, the traditional Chinese medicine composition is mixed with a pharmaceutically common matrix carrier to form an emulsion, gel, ointment, cream, patch, liniment, aerosol, spray, lotion, milk, paste, foam or drops; or the products extracted from indigo naturalis, lithospermum root and sophora flavescens are formulated into a dosage form for topical administration; or the products extracted from indigo naturalis, lithospermum root and sophora flavescens with oil or ethanol are mixed with one or more additives selected from the following: hydrocarbons, waxes, preservatives, antioxidants, surfactants, absorption enhancers, stabilizers, gelling agents, active agents, odor absorbers or fragrances.

[0013] In addition, the traditional Chinese medicine composition for treating psoriasis is an external traditional Chinese medicine composition extract for treating skin diseases extracted from indigo naturalis, lithospermum root and sophora flavescens with oil or ethanol respectively, and the external traditional Chinese medicine composition extract contains indirubin, indigotin, shikonin and oxymatrine as effective active ingredients.

[0014] On the other hand, the traditional Chinese medicine composition for treating psoriasis comprises effective active ingredients: indigo 0.0009 - 0.0182 mg / cm 2 , indirubin 0.0005 - 0.0662 mg / cm 2 , shikonin 0.00001 - 0.0117 mg / cm 2 and oxymatrine 0.0003 - 0.1138 mg / cm 2 , and the effective ingredients can all effectively reduce the total PASI score of the psoriasis mouse model.

[0015] On the other hand, the traditional Chinese medicine composition for treating psoriasis comprises effective active ingredients: indigo 0.0023 - 0.0182 mg / cm 2 , indirubin 0.0005 - 0.0662 mg / cm 2 , shikonin 0.00004 - 0.0038 mg / cm 2 and oxymatrine 0.0016 - 0.1138 mg / cm 2 , and the effective ingredients can all effectively reduce the erythema score of the psoriasis mouse model.

[0016] On the other hand, the traditional Chinese medicine composition for treating psoriasis comprises effective active ingredients: indigo 0.0009 - 0.0178 mg / cm 2 , indirubin 0.0005 - 0.0662 mg / cm 2 , shikonin 0.00001 - 0.0117 mg / cm 2 and oxymatrine 0.0003 - 0.1138 mg / cm 2 , and the effective ingredients can all effectively reduce the skin thickness score of the psoriasis mouse model.

[0017] On the other hand, the traditional Chinese medicine composition for treating psoriasis comprises effective active ingredients: indigo 0.001 - 0.0178 mg / cm 2 , indirubin 0.0005 - 0.016 mg / cm 2 , shikonin 0.00001 - 0.00411 mg / cm 2 and oxymatrine 0.0003 - 0.1084 mg / cm 2 , and the effective ingredients can all effectively reduce the scale score of the psoriasis mouse model.

[0018] According to the second aspect of the technical solution of the present invention, there is provided a use of the traditional Chinese medicine composition for treating psoriasis as described in any one of the above for preparing an external medicine for treating psoriasis.

[0019] Furthermore, the traditional Chinese medicine composition for treating psoriasis is prepared into a pharmaceutically acceptable external preparation and applied to the diseased skin area.

[0020] According to the third aspect of the technical solution of the present invention, a preparation method of a traditional Chinese medicine composition for treating psoriasis is provided, which comprises the following steps: Step S1: Use a mechanical steel mill to finely grind the traditional Chinese medicine raw materials into fine powder, pass through a 100-mesh sieve to obtain a fine powder mixture, and set aside; Step S2: Weigh, and weigh the traditional Chinese medicine raw materials in step S1 according to parts by mass, and stir evenly; Step S3: Extract the active ingredients, and extract the fine powder mixture described in step S2 with oil or ethanol to obtain the active ingredients of the traditional Chinese medicine composition.

[0021] Further, the extraction of the active ingredients in step S3 is to soak the fine powder mixture obtained in step S2 in oil for more than 10 days at a temperature of 20-25 °C, and then centrifuge to obtain the active ingredients in the supernatant.

[0022] Further, in step S3, add anhydrous ethanol at a liquid-to-material ratio of 5-25 mL / g and reflux extract at a temperature of 70-100 °C for 1-3 h, repeat the extraction 1-3 times, combine the supernatant, recover ethanol, and obtain the active ingredients in the traditional Chinese medicine composition through concentration and vacuum drying.

[0023] According to the fourth aspect of the technical solution of the present invention, a preparation method of a traditional Chinese medicine composition for treating psoriasis is provided. Based on any one of the above-mentioned traditional Chinese medicine compositions for treating psoriasis, the products of indigo naturalis, lithospermum root, and sophora flavescens extracted with oil or ethanol are mixed with one or more additives selected from the following: hydrocarbons, waxes, preservatives, antioxidants, surfactants, absorption enhancers, stabilizers, gelling agents, active agents, odor absorbers, or fragrances; wherein the products of indigo naturalis, lithospermum root, and sophora flavescens extracted with oil or ethanol are prepared by a method comprising the following steps: Extract indigo naturalis, lithospermum root, and sophora flavescens with oil at a temperature of 20-25 °C to obtain the crude product of indigo naturalis, lithospermum root, and sophora flavescens extracted with oil; extract indigo naturalis, lithospermum root, and sophora flavescens with ethanol under heating conditions at a temperature of 80 °C to obtain the crude product of indigo naturalis, lithospermum root, and sophora flavescens extracted with ethanol.

[0024] Further, the hydrocarbons are selected from petrolatum, white petrolatum, or a combination thereof.

[0025] Further, the waxes are selected from beeswax, paraffin wax, yellow wax, or a combination thereof.

[0026] According to the fifth aspect of the technical solution of the present invention, there is provided a use of an external medicine for treating psoriasis, and the external medicine for treating psoriasis is derived from indigo naturalis or indigo-producing plant extract or indirubin-producing extract for external use in treating skin diseases, and the indigo naturalis or indigo-producing plant extract or indirubin-producing extract is used for external treatment of skin diseases.

[0027] Compared with the prior art, the present invention has the following beneficial effects: 1. The present invention combines traditional Chinese medicine components and skin protection components in the form of a compound preparation and acts through the internal and external aspects together, making the therapeutic effect more comprehensive. It can fundamentally relieve the symptoms of skin diseases, and its all-natural ingredient composition has low side effects and no hormone dependence.

[0028] 2. Based on the treatment test on a psoriasis mouse model induced by imiquimod cream, the present invention has a significant curative effect, can effectively reduce the PASI score, and promote the regression of skin lesions. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1-1 shows the results of mouse pathological sections of normal mice, model group and drug group in the test example according to the present invention; among them, Figure 1-1a 、 Figure 1-1b are the results of mouse pathological sections of normal mice, Figure 1-1c 、 Figure 1-1d are the results of mouse pathological sections of the model group, Figure 1-1e 、 Figure 1-1f are the results of mouse pathological sections of the positive tretinoin drug group; they are observed under a 10-fold microscope and a 20-fold microscope respectively; Figure 1-2 shows the results of mouse pathological sections of the group using the herbal moistening and dryness relieving ointment in the test example according to the present invention; among them, Figure 1-2a is the result of mouse pathological section with normal keratinization of most cells and reduced acanthosis, Figure 1-2b is the result of mouse pathological section with reduced inflammatory cell infiltration, Figure 1-2c is the result of mouse pathological section with hair growing in the hair follicles; Figure 2 is a schematic diagram of the pharmacodynamic comparison results of different doses of compound a ointment in treating a psoriasis mouse model; Figure 3 is the pharmacodynamic result of the medium-dose compound a ointment in treating a psoriasis mouse model; Figure 4 is the pharmacodynamic result of different doses of compound b ointment in treating a psoriasis mouse model; Figure 5 is the pharmacodynamic result of compound b-j ointment in treating a psoriasis mouse model; Figure 6 Pharmacodynamic results of different doses of compound k ointment in treating a psoriasis mouse model; Figure 7 are the pharmacodynamic results of ointments of different monomeric compounds in treating a psoriasis mouse model; Figure 8 are the pharmacodynamic results of an ointment of a monomeric composition in treating a psoriasis mouse model; Figure 9 Chromatogram of 4 chemical components in the reference solution of the present invention; Figure 10 is the chemical structural formula diagram of 4 test components in the test solution of the present invention. Detailed Embodiments

[0030] In order to make the technical problems to be solved, the technical solutions adopted and the beneficial effects obtained by the present invention clearer and more understandable, the present invention will be further described in detail below with reference to specific embodiments. The specific embodiments described herein are only used to explain the present invention and do not constitute any limitation to the present invention. Unless otherwise defined, all terms used in the present invention have the same meaning as commonly used in the field to which the present invention belongs.

[0031] The following provides specific embodiments to help understand the present invention. It should be understood that the embodiments and test examples listed in the present invention are only used to illustrate the present invention, but do not constitute any limitation. The actual protection scope of the present invention is set forth in the claims.

[0032] The present invention provides a traditional Chinese medicine composition for treating psoriasis, its preparation method and uses, specifically as follows: There is provided a traditional Chinese medicine composition for treating psoriasis, which is made from the following traditional Chinese medicine raw materials by mass parts: 10 - 20 parts of indigo naturalis, 3 - 8 parts of lithospermum root, 8 - 12 parts of coptis root, 3 - 8 parts of zedoary turmeric, and 200 - 300 parts of camellia oil added; or 200 - 300 parts of indigo naturalis, 80 - 120 parts of lithospermum root powder, 80 - 120 parts of sophora flavescens powder, and 1000 - 1500 parts of camellia oil; or 10 - 80 parts of indigo naturalis, 8 - 70 parts of lithospermum root, and 12 - 80 parts of sophora flavescens powder.

[0033] Preferably, the traditional Chinese medicine composition for treating psoriasis is made from the following traditional Chinese medicine raw materials by mass parts: 15 parts of indigo naturalis, 5 parts of lithospermum root, 10 parts of coptis root, 5 parts of zedoary turmeric, and 250 parts of camellia oil added.

[0034] Preferably, the traditional Chinese medicine composition for treating psoriasis is made from the following traditional Chinese medicine raw materials by mass parts: 250 parts of indigo naturalis, 100 parts of lithospermum root, 100 parts of sophora flavescens, and 1250 parts of camellia oil.

[0035] Preferably, the traditional Chinese medicine composition for treating psoriasis is made from the following traditional Chinese medicine raw materials by mass parts: 16 - 56 parts of indigo naturalis, 11 - 50 parts of lithospermum root, and 16 - 50 parts of sophora flavescens.

[0036] Furthermore, in the traditional Chinese medicine raw materials, indigo naturalis is used in the form of indigo naturalis powder, lithospermum root is used in the form of lithospermum root oil, coptis root is used in the form of coptis root powder, zedoary turmeric root tuber is used in the form of zedoary turmeric root tuber oil, or sophora flavescens is used in the form of sophora flavescens powder.

[0037] More preferably, in the traditional Chinese medicine raw materials, there are 15 parts of indigo naturalis powder, 5 parts of lithospermum root oil, 10 parts of coptis root powder, 5 parts of zedoary turmeric root tuber oil, and 250 parts of camellia oil are added.

[0038] More preferably, in the traditional Chinese medicine raw materials, there are 250 parts of indigo naturalis powder, 100 parts of lithospermum root powder, and 100 parts of sophora flavescens powder. After soaking in 1250 parts of camellia oil and centrifuging to obtain the supernatant, the active ingredients are obtained to form an extract paste.

[0039] More preferably, there are 16 - 50 parts of indigo naturalis powder, 10 - 50 parts of lithospermum root powder, and 10 - 50 parts of sophora flavescens powder. Ethanol is added at a liquid - to - solid ratio of 15 mL / g and refluxed at 80 °C for 2 h, and the extraction is repeated 3 times. The supernatant is combined, ethanol is recovered, and after concentration and vacuum drying, an extract paste is obtained.

[0040] Furthermore, the traditional Chinese medicine composition is mixed with a pharmaceutically common matrix carrier to form an emulsion, gel, ointment, cream, patch, liniment, aerosol, spray, lotion, milk, paste, foam or drop; or the products extracted from indigo naturalis, lithospermum root and sophora flavescens are formulated into a dosage form for local administration; or the products extracted from indigo naturalis, lithospermum root and sophora flavescens with oil or ethanol are mixed with one or more additives selected from the following: hydrocarbons, waxes, preservatives, antioxidants, surfactants, absorption enhancers, stabilizers, gelling agents, active agents, odor absorbers or fragrances.

[0041] In addition, the traditional Chinese medicine composition for treating psoriasis is an external traditional Chinese medicine composition extract for treating skin diseases, which is extracted from indigo naturalis, lithospermum root and sophora flavescens with oil or ethanol respectively. The external traditional Chinese medicine composition extract contains indirubin, indigotin, shikonin and oxymatrine as effective active ingredients.

[0042] On the other hand, the traditional Chinese medicine composition for treating psoriasis includes effective active ingredients: indirubin 0.0009 - 0.0182 mg / cm 2 , indigotin 0.0005 - 0.0662 mg / cm 2 , shikonin 0.00001 - 0.0117 mg / cm 2 and oxymatrine 0.0003 - 0.1138 mg / cm 2 , and all the effective ingredients can effectively reduce the total PASI score of the psoriasis mouse model.

[0043] On the other hand, the traditional Chinese medicine composition for treating psoriasis includes effective active ingredients: indirubin 0.0023 - 0.0182 mg / cm 2, indirubin 0.0005 - 0.0662 mg / cm 2 , shikonin 0.00004 - 0.0038 mg / cm 2 and oxymatrine 0.0016 - 0.1138 mg / cm 2 , and the active ingredients can effectively reduce the erythema score of the psoriasis mouse model.

[0044] On the other hand, the traditional Chinese medicine composition for treating psoriasis includes active ingredients: indigo 0.0009 - 0.0178 mg / cm 2 , indirubin 0.0005 - 0.0662 mg / cm 2 , shikonin 0.00001 - 0.0117 mg / cm 2 and oxymatrine 0.0003 - 0.1138 mg / cm 2 , and the active ingredients can effectively reduce the skin thickness score of the psoriasis mouse model.

[0045] On the other hand, the traditional Chinese medicine composition for treating psoriasis includes active ingredients: indigo 0.001 - 0.0178 mg / cm 2 , indirubin 0.0005 - 0.016 mg / cm 2 , shikonin 0.00001 - 0.00411 mg / cm 2 and oxymatrine 0.0003 - 0.1084 mg / cm 2 , and the active ingredients can effectively reduce the scale score of the psoriasis mouse model.

[0046] In another embodiment, there is provided the use of the traditional Chinese medicine composition for treating psoriasis as described in any one of the above for preparing an external medicine for treating psoriasis.

[0047] Furthermore, the traditional Chinese medicine composition for treating psoriasis is prepared into a pharmaceutically acceptable external preparation and applied to the diseased skin area.

[0048] In another embodiment, there is provided a preparation method of the traditional Chinese medicine composition for treating psoriasis, which comprises the following steps: Step S1: Use a mechanical steel mill to finely grind the traditional Chinese medicine raw materials into fine powder, pass through a 100 - mesh sieve to obtain a fine powder mixture, and set aside; Step S2: Weigh, and weigh the traditional Chinese medicine raw materials in step S1 according to parts by mass, and stir evenly; Step S3: Extract the active ingredients, and extract the fine powder mixture in step S2 with oil or ethanol to obtain the active ingredients of the traditional Chinese medicine composition.

[0049] Further, in step S3 for extracting the active ingredient, the fine powder mixture obtained in step S2 is soaked in oil for more than 10 days at a temperature of 20-25 °C, and then centrifuged to obtain the active ingredient in the supernatant.

[0050] Further, in step S3, anhydrous ethanol is added at a liquid-to-material ratio of 5-25 mL / g and refluxed for 1-3 h at a temperature of 70-100 °C. The extraction is repeated 1-3 times, and the supernatant is combined. The ethanol is recovered, concentrated, and dried under reduced pressure to obtain the active ingredient in the traditional Chinese medicine composition.

[0051] In another embodiment, a preparation method of a traditional Chinese medicine composition for treating psoriasis is provided. According to any one of the above-mentioned traditional Chinese medicine compositions for treating psoriasis, the products of indigo naturalis, lithospermum root, and sophora flavescens extracted by oil or ethanol are mixed with one or more additives selected from the following: hydrocarbons, waxes, preservatives, antioxidants, surfactants, absorption enhancers, stabilizers, gelling agents, active agents, odor absorbers, or fragrances; wherein the products of indigo naturalis, lithospermum root, and sophora flavescens extracted by oil or ethanol are prepared by a method comprising the following steps: Indigo naturalis, lithospermum root, and sophora flavescens are extracted with oil at a temperature of 20-25 °C to obtain a crude product of indigo naturalis, lithospermum root, and sophora flavescens extracted by oil; indigo naturalis, lithospermum root, and sophora flavescens are extracted with ethanol under heating at a temperature of 80 °C to obtain a crude product of indigo naturalis, lithospermum root, and sophora flavescens extracted by ethanol.

[0052] Further, the hydrocarbon is selected from petrolatum, white petrolatum, or a combination thereof.

[0053] Further, the wax is selected from beeswax, paraffin wax, yellow wax, or a combination thereof.

[0054] According to the fifth aspect of the technical solution of the present invention, a use of an external medicine for treating psoriasis is provided. The external medicine for treating psoriasis is derived from indigo naturalis or an indigo plant extract or an indirubin extract for external use in treating skin diseases, and the indigo naturalis or an indigo plant extract or an indirubin extract is used for external treatment of skin diseases.

[0055] The present invention is further described below in combination with the functions and effects of the traditional Chinese medicine composition for treating psoriasis, its preparation method, and use of the present invention: The traditional Chinese medicine composition for treating psoriasis of the present invention uses indigo naturalis and lithospermum root as the basic formula, supplemented with camellia oil, and coptis root, sophora flavescens and zedoary turmeric or their different combinations are respectively added in different compatibilities to obtain traditional Chinese medicine compositions for treating psoriasis with different curative effects. The present invention extracts the effective components of lithospermum root and zedoary turmeric to obtain lithospermum root oil and zedoary turmeric oil respectively; indigo naturalis, coptis root, sophora flavescens and lithospermum root are ground to obtain indigo naturalis powder, coptis root powder, sophora flavescens powder and lithospermum root powder respectively, and the ground powders and / or the extracted effective components are compatibly formulated according to mass parts to obtain traditional Chinese medicine compositions for treating psoriasis with different curative effects; further, the effective components of indigo naturalis are extracted to obtain active ingredients such as indigo and indirubin, and the effective components of lithospermum root and sophora flavescens are extracted to obtain active ingredients such as shikonin and oxymatrine respectively, and different ointments and pharmaceutically realizable dosage forms are formulated based on the obtained active ingredients for treating psoriasis.

[0056] In one embodiment, different combinations are made based on extracting the effective active monomer components of each component, such as oxymatrine, shikonin, indigo, indirubin, etc., and the paired combination of oxymatrine - indigo is used to obtain different ointments and pharmaceutically realizable dosage forms; in another embodiment, the above-mentioned effective ingredient raw materials are mixed with a matrix carrier (such as beeswax) to form an emulsion, gel, ointment, cream, patch, liniment, aerosol, spray, lotion, milk slurry, paste, foam or drop, in the form of a single or multiple doses.

[0057] The traditional Chinese medicine composition for treating psoriasis of the present invention can be used as an external traditional Chinese medicine composition for treating skin diseases. Its compound traditional Chinese medicine composition or monomer component can be mixed with a matrix carrier (such as beeswax) to form an emulsion, gel, ointment, cream, patch, liniment, aerosol, spray, lotion, milk slurry, paste, foam or drop, in the form of a single or multiple doses.

[0058] Further, the extracts of indigo naturalis, lithospermum root and sophora flavescens in the traditional Chinese medicine composition for treating psoriasis of the present invention are respectively extracted with oil or ethanol to obtain external traditional Chinese medicine composition extracts for treating skin diseases. The external traditional Chinese medicine composition extracts contain effective active ingredients such as indigo, indirubin, shikonin and oxymatrine. The effective active ingredients are added to a matrix carrier (such as beeswax) to form a traditional Chinese medicine combination test ointment that can treat psoriasis. For example, the traditional Chinese medicine combination test ointment contains effective active ingredient indigo 0.0009 - 0.0182 mg / cm 2 、indirubin 0.0005 - 0.0662 mg / cm 2 、shikonin 0.00001 - 0.0117 mg / cm 2 and oxymatrine 0.0003 - 0.1138 mg / cm 2, which can effectively reduce the total PASI score of the psoriasis mouse model; the test ointment of the traditional Chinese medicine combination contains the active ingredient indigo at 0.0023 - 0.0182 mg / cm 2 , indirubin at 0.0005 - 0.0662 mg / cm 2 , shikonin at 0.00004 - 0.0038 mg / cm 2 and oxymatrine at 0.0016 - 0.1138 mg / cm 2 , which can effectively reduce the erythema score of the psoriasis mouse model. The test ointment of the traditional Chinese medicine combination contains the active ingredient indigo at 0.0009 - 0.0178 mg / cm 2 , indirubin at 0.0005 - 0.0662 mg / cm 2 , shikonin at 0.00001 - 0.0117 mg / cm 2 and oxymatrine at 0.0003 - 0.1138 mg / cm 2 , which can effectively reduce the skin thickness score of the psoriasis mouse model. The test ointment of the traditional Chinese medicine combination contains the active ingredient indigo at 0.001 - 0.0178 mg / cm 2 , indirubin at 0.0005 - 0.016 mg / cm 2 , shikonin at 0.00001 - 0.00411 mg / cm 2 and oxymatrine at 0.0003 - 0.1084 mg / cm 2 , which can effectively reduce the scale score of the psoriasis mouse model.

[0059] In another embodiment, the single component of oxymatrine can be mixed with a matrix carrier (such as beeswax) to form an ointment, cream, gel, liniment or film-forming agent, which can effectively reduce the skin thickness score of the psoriasis mouse model. The single component of shikonin can effectively reduce the total PASI score and skin thickness score of the psoriasis mouse model, and the single component of indirubin can effectively reduce the skin thickness score of the psoriasis mouse model; the paired combination of oxymatrine - indigo can effectively reduce the total PASI score, erythema score, skin thickness score and scale score of the psoriasis mouse model. In another embodiment, the traditional Chinese medicine composition for treating psoriasis contains the products extracted from indigo naturalis, lithospermum and sophora flavescens, and is formulated into a dosage form for topical administration; it is made from the following traditional Chinese medicine raw materials in parts by mass: 10 - 20 parts of indigo naturalis, 3 - 8 parts of lithospermum, 8 - 12 parts of coptis chinensis, 3 - 8 parts of zedoary turmeric, and 200 - 300 parts of camellia oil; or 200 - 300 parts of indigo naturalis, 80 - 120 parts of lithospermum powder, 80 - 120 parts of sophora flavescens powder, and 1000 - 1500 parts of camellia oil; or 10 - 80 parts of indigo naturalis, 8 - 70 parts of lithospermum, and 12 - 80 parts of sophora flavescens powder.

[0060] The basic mechanism of traditional Chinese medicine in this invention is as follows: Psoriasis is caused by multiple factors, such as deficiency of nutrient blood in the body, generation of wind from blood deficiency, and loss of nourishment of the skin; or accumulation of wind-heat in the skin, generation of wind from blood heat; repeated attacks due to loss of nourishment of the skin, and when heat accumulates for a long time, it will flow into the joints, blocking the meridians; in severe cases, internal toxin is exuberant and both qi and blood are blazing; the main skin lesions are scales and erythema, and its course of disease is lingering and repeated, difficult to cure. Among the components of this invention, indigo naturalis can be obtained from one or more indigo-containing plants, including indigofera tinctoria, baphicacanthus cusia, polygonum tinctorium, isatis indigotica, and / or baphicacanthus formosanus, with salty and cold nature, having the effects of clearing heat and detoxifying, cooling blood and eliminating macules, purging fire and calming fright, etc., and externally using for detoxifying dampness, detumescence and pain relief; lithospermum erythrorhizon is an important drug for cooling blood, having the functions of cooling blood, promoting blood circulation, detoxifying, clearing heat and relieving pain, removing necrosis and promoting granulation; coptis chinensis, with bitter and extremely cold taste, is necessary for treating itching sores, macule toxin measles sores, and excessive pathogenic heat; curcuma zedoaria has warm nature, pungent and bitter taste, and the effects of promoting blood circulation to remove stasis, eliminating accumulation and relieving pain; sophora flavescens can cool blood, relieve heat toxin, treat scabies, pustular eczema toxin, relieve skin itching, blood wind tinea sores, and stubborn white scales; and camellia oil contains rich natural vitamin E, tea polyphenols, and squalene, having the effect of beauty and anti-aging; beeswax has sweet, light taste, mild nature and non-toxic, having the functions of tonifying qi and nourishing blood, expelling wind and moistening dryness, and harmonizing blood and detoxifying.

[0061] The present invention will be further illustrated by multiple specific examples and test examples below.

[0062] Example 1 The raw materials of the active ingredients of the test ointment in Example 1 include: 15 parts of indigo naturalis, 5 parts of lithospermum erythrorhizon, 10 parts of coptis chinensis powder, 5 parts of curcuma zedoaria oil, and 250 parts of camellia oil are added.

[0063] The external medicine with the traditional Chinese medicine components in Example 1 can be mixed with a matrix carrier (such as beeswax) to form an emulsion, gel, ointment, cream, patch, liniment, aerosol, spray, lotion, milk, paste, foam or drop, in the form of a single or multiple doses.

[0064] Test Example 1 1.1 Safety test.

[0065] Test method: 4 New Zealand white rabbits of ordinary grade, with body weight of 1.80 - 2.20 kg. 24 hours before the test, the hair on both sides of the back spine of the experimental animals was cut off, and the hair removal area was 3×3 cm for each side. 2 .

[0066] Take 0.5 mL of the test substance and apply it on one side of the skin, with the application area of 2.5×2.5 cm. 2 , and the other side is not treated as a control. Apply it once a day for 14 consecutive days. From the second day, cut the hair before each application and remove the residual test substance with pure water. Observe the results one hour later and score according to Table 1 of the skin irritation and corrosion test in the "Technical Specifications for Cosmetics Safety" (2015 edition). The control area and the test area are treated in the same way.

[0067] The results were used to determine the skin irritation intensity of rabbits according to Table 2 of the Skin Irritation and Corrosion Test in the Technical Specifications for Cosmetic Safety (2015 Edition). Other symptoms besides skin irritation were observed during the experiment.

[0068] Test results: By statistically analyzing the skin irritation response scores of each animal every day for 14 days, it was determined that the ointment obtained in Example 1 was non-irritating to the animal skin.

[0069] 1.2 Pharmacodynamic experiments.

[0070] Test method: Twenty SPF-grade C57 female mice, 7 - 8 weeks old with standard body weight, were randomly divided into 4 groups, including a normal control group, a positive drug group of tretinoin cream, a model group, and a test ointment group. One day before modeling, the back hair of the mice was removed with a hair clipper, with an area of about 2×3 cm 2 . The normal control group was not given any drug. In other groups, imiquimod cream was evenly applied to induce a psoriasis model, 20 mg per mouse per day for 14 consecutive days. Among them, starting from the fourth day of modeling, imiquimod cream was applied in the morning to induce the model, and the positive drug or the test ointment was applied in the afternoon. The amount of the test ointment applied was about 1 mm thick to cover the psoriasis modeling area. Tretinoin cream was administered once a day according to the instructions, and the normal control group was not treated. Twenty-four hours after the last application, the mice were sacrificed by cervical dislocation, and skin tissues were taken. After being fixed with formaldehyde, dehydrated, embedded, sectioned, stained with H&E, etc., they were observed and photographed under a microscope.

[0071] Experimental results: Figure 1-1a - Figure 1-1f They were based on the pathological section results of normal mice, the model group, and the drug group in the test examples of the present invention; among them, Figure 1-1a 、 Figure 1-1b were the pathological section results of normal mice, Figure 1-1c 、 Figure 1-1d were the pathological section results of the model group, Figure 1-1e 、 Figure 1-1f were the pathological section results of the positive drug group of tretinoin; they were observed using a 10× and 20× microscope respectively. Through the pathological section results of normal mice shown in Figure 1-1a 、 Figure 1-1b , and the pathological section results of the model group shown in Figure 1-1c 、 Figure 1-1d , it could be shown that: parakeratosis, infiltration of neutrophils and lymphocytes; thinning or disappearance of the granular layer, acanthosis, and acute inflammation. Through the pathological section results of the positive drug group of tretinoin shown in Figure 1-1e 、 Figure 1-1f , it could be shown that: parakeratosis was still persistent, and the granular layer was very obvious; acanthosis, and the infiltration of inflammatory cells was reduced.

[0072] Figure 1-2a - Figure 1-2care the results of the pathological sections of the mice in the group using the herbal moistening and dryness relieving ointment in the test examples of the present invention; among them, Figure 1-2a are the results of the pathological sections of the mice with normal keratinization of most cells and reduced acanthosis, Figure 1-2b are the results of the pathological sections of the mice with reduced infiltration of inflammatory cells, Figure 1-2c are the results of the pathological sections of the mice with hair growing in the hair follicles. Through Figure 1-2a - Figure 1-2c it can be seen that: the keratinization of most cells is normal and the acanthosis is reduced; the infiltration of inflammatory cells is reduced; hair grows in the hair follicles. And the following phenomena are shown: 1. The pathological changes in the psoriasis mouse model, such as parakeratosis, acanthosis, infiltration of neutrophils and lymphocytes, thinning or disappearance of the granular layer and other typical pathological manifestations of psoriasis; 2. Parakeratosis persists, acanthosis is present, the granular layer is very obvious, and the infiltration of inflammatory cells is reduced. 3. After 11 days of use of the herbal moistening and dryness relieving ointment, through pathological tissue observation, the keratinization of most cells is normal, the acanthosis is reduced, the infiltration of inflammatory cells is significantly reduced, and hair grows in the hair follicles.

[0073] It can be known from Test Example 1 that: compared with the normal group, obvious parakeratosis, infiltration of neutrophils and lymphocytes, thinning or disappearance of the granular layer, acanthosis, acute inflammation and other typical pathological manifestations of psoriasis can be seen in the skin tissues of the mice in the model group. In the positive drug group, parakeratosis continues, the granular layer is already very obvious, acanthosis is present, and the infiltration of inflammatory cells is reduced. In the group of the test ointment, the keratinization of most cells in the skin tissues is normal, the acanthosis is reduced, the infiltration of inflammatory cells is reduced, and hair grows in the hair follicles.

[0074] The pharmacodynamic results show that the traditional Chinese medicine composition ointment of Example 1 has a significant therapeutic effect on the skin tissues of C57 mice with psoriasis.

[0075] Example 2 The active ingredients of the traditional Chinese medicine composition are prepared according to the following steps.

[0076] Step S1: Use a mechanical steel mill to finely grind indigo naturalis, lithospermum erythrorhizon and sophora flavescens into fine powders respectively, pass through a 100-mesh sieve to obtain a fine powder mixture, and set aside; Step S2: Weigh, and weigh the traditional Chinese medicine raw materials in Step S1 according to 250 parts of indigo naturalis powder, 100 parts of lithospermum erythrorhizon powder, and 100 parts of sophora flavescens powder, and stir evenly; Step S3: By mass, take 1250 parts of camellia oil, that is, the mass ratio of indigo naturalis: lithospermum erythrorhizon: sophora flavescens: camellia oil is 5:2:2:25, soak at 20-25 °C for 20 days, and then centrifuge to take the active ingredients in the supernatant.

[0077] Take the active ingredients in Example 2 and beeswax, and prepare Compound a Ointment according to the mass ratio of 25:4 by mass.

[0078] Test Example 2 (1)Forty 6 - 8 - week - old male BALB / c mice with standard body weight were randomly divided into 6 groups, including a normal control group, a calcipotriol ointment positive drug group, a model group, and low, medium, and high - dose groups of compound a ointment. One day before modeling, a hair clipper was used to remove the hair on the back of the mice, and then depilatory cream was used to completely remove the hair, with an area of 2×5 cm 2 . In the normal control group, vaseline was applied to the back. In other groups, imiquimod cream was evenly applied to induce a psoriasis model, 62.5 mg per mouse per day for 10 consecutive days. Among them, starting from the fifth day of modeling, imiquimod cream was applied in the morning to induce the model, and 50 mg of the positive drug or 50 mg, 100 mg, 200 mg of the test ointment was applied in the afternoon. The normal control group was given the ointment base. The grouping of experimental animals and the drug dosage are shown in Table 1. During the modeling and treatment periods, the skin lesions of the mice were photographed before drug administration for PASI scoring.

[0079] (2)Forty 6 - 8 - week - old male BALB / c mice with standard body weight were randomly divided into 4 groups, including a normal control group, a calcipotriol ointment positive drug group, a model group, and a compound a ointment usage group. One day before modeling, a hair clipper was used to remove the hair on the back of the mice, and then depilatory cream was used to completely remove the hair, with an area of 2×5 cm 2 . In the normal control group, vaseline was applied to the back. In other groups, imiquimod cream was evenly applied to induce a psoriasis model, 62.5 mg per mouse per day for 10 consecutive days. Among them, starting from the sixth day of modeling, imiquimod cream was applied in the morning to induce the model, and 50 mg of the positive drug or 100 mg of compound a ointment was applied in the afternoon. The normal control group was given the ointment base. The grouping of experimental animals and the drug dosage are shown in Table 2. During the modeling and treatment periods, the skin lesions of the mice were photographed before drug administration for PASI scoring.

[0080] PASI scoring criteria: 0 (none): There are no visible erythema or scales on the skin surface, and the skin lesions are equivalent to normal healthy skin.

[0081] 1 (low - level): The skin lesions are partially covered with scales, mainly small pieces of dandruff. The skin lesions are slightly more advanced than normal skin and are light red.

[0082] 2 (moderate): Most of the skin is partially or completely covered with scales, with moderate ridges. The edges of the plaques are red, round or bevel - shaped.

[0083] 3 (severe): Almost the entire surface of the skin lesions is covered with thick lamellar scales. The skin lesions are thick, dark red, and have obvious elevations.

[0084] 4 (extremely severe): The entire surface of the skin lesions is covered with very thick lamellar scales. The skin lesions are very thick, extremely red, and have extremely obvious ridges.

[0085] Total score: The sum of the scores for skin erythema, thickness, and scale.

[0086] Experimental results: (1) As Figure 2 shown, for the efficacy comparison results of different doses of Compound a Ointment in treating the psoriasis mouse model, compared with the model group, 50mg, 100mg, and 200mg of Compound a Ointment could significantly reduce the erythema score at the lesion site of the model mice starting from the third day of treatment. 50mg, 100mg, and 200mg of Compound a Ointment could significantly reduce the thickness of the diseased skin of the model mice starting from the fourth day of treatment. 100mg and 200mg of Compound a could significantly and effectively reduce the scale at the lesion site of the model mice starting from the fourth day of treatment and could improve the total PASI score of the mouse model starting from the third day of treatment. The above results indicate that 100mg and 200mg of Compound a Ointment can improve the symptoms of psoriasis lesions. At the same time, the efficacy of the test ointment is superior to that of the classic topical anti-psoriasis drug, vitamin D3 analogue - calcipotriol ointment.

[0087] Based on the above results, both 100mg and 200mg of Compound a Ointment can effectively improve the symptoms of psoriasis lesions. Therefore, a dose of 100mg was selected for further efficacy verification.

[0088] (2) As Figure 3 shown, compared with the model group, 100mg of Compound a Ointment could significantly reduce the erythema score at the lesion site of the model mice starting from the second day of treatment, could significantly reduce the thickness of the diseased skin of the model mice starting from the third day of treatment, could significantly and effectively reduce the scale at the lesion site of the model mice starting from the second day of treatment, and could improve the total PASI score of the mouse model starting from the second day of treatment. The above results indicate that the test ointment can effectively improve the symptoms of psoriasis lesions. At the same time, the efficacy of the test ointment is superior to that of the classic topical anti-psoriasis drug, vitamin D3 analogue - calcipotriol ointment.

[0089] The above pharmacodynamic results show that the test ointment in this example can effectively reduce the clinical treatment indicators of psoriasis, has a significant therapeutic effect on the lesion site of the psoriasis mouse model, and at the same time helps the body weight of the psoriasis mice to recover.

[0090] Table 1 Grouping and drug application amounts of different doses of Compound a Ointment in animal experiments

[0091] Table 2 Grouping and drug application amounts of medium-dose Compound a Ointment in animal experiments

[0092] Example 3 The active ingredient of the traditional Chinese medicine composition was prepared according to the following steps, which include the following steps: Step S1: Use a mechanical steel mill to finely grind indigo naturalis, lithospermum root, and sophora flavescens into fine powders respectively, pass through a 100-mesh sieve to obtain a fine powder mixture, and set aside. Step S2: Weigh, weigh the indigo naturalis powder, lithospermum root powder, and sophora flavescens powder obtained in Step S1 according to the proportion, and stir evenly. Step S3: Add absolute ethanol at a liquid-to-material ratio of 15 mL / g and reflux for extraction at 80 °C for 2 h, repeat the extraction 3 times, combine the supernatant, recover ethanol, and obtain an extract after concentration and vacuum drying.

[0093] In Example 3, the Chinese medicine components can be mixed with a matrix carrier (such as beeswax) to form an emulsion, gel, ointment, cream, patch, liniment, aerosol, spray, lotion, milk slurry, paste, foam or drops, in the form of a single or multiple doses.

[0094] Take the extract in Example 3 and prepare it according to the mass ratio of 0.24 g of crude drug / g of ointment with camellia oil / beeswax (25:4, g / g) to obtain Compound b-j ointment in sequence. The proportion of each Chinese medicine raw material is shown in Table 4 in detail.

[0095] Test Example 3 Use the Compound b-j ointment prepared in Example 3 for testing.

[0096] Test Example 3 Experiment 1: Initially determine an effective dosing dose. In this experiment, Compound b ointment was calculated based on the effective treatment concentration in Compound a ointment, that is, with the mass ratio of indigo naturalis, lithospermum root, and sophora flavescens being 5:2:2, and the extract was obtained by extracting the active ingredients in this way. Compound b ointment was prepared according to the requirements of Example 3.

[0097] Take 40 male BALB / c mice, 6 - 8 weeks old with standard body weight, and randomly divide them into 6 groups, including a normal control group, a model group, a lowest dose group of Compound b ointment (0.06 g of crude drug / g of ointment), a low dose group (0.12 g of crude drug / g of ointment), a medium dose group (0.24 g of crude drug / g of ointment), and a high dose group (0.48 g of crude drug / g of ointment). The detailed grouping of the test animals and the drug application amount are shown in Table 3. One day before modeling, use a hair clipper to remove the hair on the back of the mice, and then use a depilatory cream to completely remove the hair, with an area of 2×5 cm 2 . Apply vaseline to the back of the normal control group, and apply imiquimod cream evenly to other groups to establish a psoriasis model, 62.5 mg per mouse per day, for 10 consecutive days. Among them, starting from the sixth day of modeling, apply imiquimod cream in the morning to establish the model, and apply 100 mg of Compound b ointment at different concentration doses in the afternoon. The normal control group is given the ointment matrix. During the modeling and treatment periods, take pictures of the skin lesions of the mice before drug administration for PASI scoring.

[0098] Test Example 3, Experiment 2: Based on the screening results of the drug efficacy doses in Test Example 3, Experiment 1, 0.24 g of crude drug / g of ointment was selected as the administration concentration for this orthogonal experiment to conduct an orthogonal experiment on the optimal ratio of the three medicinal materials, that is, using Compound b-j Ointment for efficacy treatment.

[0099] 85 male BALB / c mice, 6 - 8 weeks old with standard body weight, were randomly divided into 11 groups, including a normal control group, a model group, and a Compound b-j Ointment group (both at 0.24 g of crude drug / g of ointment). One day before modeling, a hair clipper was used to remove the hair on the backs of the mice, and then depilatory cream was used to completely remove the hair, with an area of 2×5 cm. 2 . Vaseline was applied to the backs of the mice in the normal control group, and imiquimod cream was evenly applied to the other groups to establish a psoriasis model, 62.5 mg per mouse per day for 10 consecutive days. Among them, starting from the sixth day of modeling, imiquimod cream was applied in the morning for modeling, and 100 mg of the test ointment was applied in the afternoon. The ointment base was given to the normal control group. The grouping of animals and the dosage of drugs in the orthogonal experiment are shown in Table 4. During the modeling and treatment periods, the skin lesions of the mice were photographed before drug administration for PASI scoring.

[0100] Test Example 3, Experiment 2: Based on the orthogonal experiment results of Test Example 3, Experiment 2, the optimal ratio of the medicinal materials was Indigo Naturalis: Lithospermum erythrorhizon: Sophora flavescens = 5:1:3. The extract was obtained by extracting the active ingredients based on this ratio. Compound k Ointment was prepared according to the requirements of Example 3.

[0101] 40 male BALB / c mice, 6 - 8 weeks old with standard body weight, were randomly divided into 5 groups, including a normal control group, a model group, a low-dose group of Compound k Ointment (0.12 g of crude drug / g of ointment), a medium-dose group (0.24 g of crude drug / g of ointment), and a high-dose group (0.48 g of crude drug / g of ointment). One day before modeling, a hair clipper was used to remove the hair on the backs of the mice, and then depilatory cream was used to completely remove the hair, with an area of 2×5 cm. 2 . Vaseline was applied to the backs of the mice in the normal control group, and imiquimod cream was evenly applied to the other groups to establish a psoriasis model, 62.5 mg per mouse per day for 10 consecutive days. Among them, starting from the sixth day of modeling, imiquimod cream was applied in the morning for modeling, and 100 mg of Compound k Ointment with different concentration doses was applied in the afternoon. The ointment base was given to the normal control group. The grouping of animals and the dosage of drugs in the efficacy test of Compound k Ointment are shown in Table 5. During the modeling and treatment periods, the skin lesions of the mice were photographed before drug administration for PASI scoring.

[0102] PASI scoring criteria: 0 (none): No visible erythema or scales on the skin surface, and the skin lesions are equivalent to normal healthy skin.

[0103] 1 (low level): Part of the skin lesions are covered with scales, mainly small pieces of dandruff. The skin lesions are slightly more advanced than normal skin and are light red.

[0104] 2 (Moderate): Most of the skin is partially or completely covered with scales, with moderate ridges, and the edges of the plaques are red, round or beveled.

[0105] 3 (Severe): Almost the entire surface of the skin lesion is covered with thick laminated scales, the skin lesion is thick, dark red, and has obvious elevations.

[0106] 4 (Extremely severe): The entire surface of the skin lesion is covered with very thick laminated scales, the skin lesion is very thick, extremely red in color, and has extremely obvious ribbing.

[0107] Total score: The sum of the scores for skin erythema, thickness, and scales.

[0108] Experimental results: (1) As Figure 4 shown, compared with the model group, Compound b ointment in the lowest dose group could significantly reduce the erythema score at the skin lesion site of model mice starting from the fourth day of treatment, and Compound b ointment in the low, medium, and high dose groups could significantly reduce the erythema score of model mice starting from the fifth day of treatment; Compound b ointment in the medium and high dose groups could significantly reduce the thickness of the diseased skin of model mice starting from the fifth day of treatment; Compound b ointment in the lowest dose group could improve the total PASI score of the mouse model starting from the fourth day of treatment, and Compound b ointment in the medium and high dose groups could improve the total PASI score of the mouse model starting from the fifth day of treatment.

[0109] Based on the above results, Compound b ointment in the medium and high dose groups could effectively improve the symptoms of psoriasis skin lesions, so the medium dose (0.24 g of crude drug / g of ointment) was selected for further verification of the drug effect.

[0110] (2) As Figure 5 shown, compared with the model group, Compound e ointment could significantly reduce the erythema score at the skin lesion site of model mice starting from the fourth day of treatment; Compound e and g ointments could significantly reduce the thickness of the diseased skin of model mice starting from the third day of treatment, Compound d ointment could significantly reduce the thickness of the diseased skin of model mice starting from the fifth day of treatment, and Compound b, c, d, e, f, g, and i ointments could significantly reduce the thickness of the diseased skin of model mice on the sixth day of treatment; Compound e ointment could significantly reduce the scales at the skin lesion site of model mice starting from the second day of treatment, Compound d and g ointments could significantly reduce the scales at the skin lesion site of model mice starting from the third day of treatment, and Compound b, c, d, e, f, g, and i ointments could significantly reduce the scales at the skin lesion site of model mice on the sixth day of treatment; Compound e ointment could improve the total PASI score of the mouse model starting from the third day of treatment, Compound d ointment could improve the total PASI score of the mouse model starting from the fourth day of treatment, and Compound g and i ointments could improve the total PASI score of the mouse model on the sixth day of treatment.

[0111] (3) As Figure 6As shown, compared with the model group, the low-dose and medium-dose compound K ointment could significantly reduce the thickness of the lesioned skin of model mice starting from the second day of treatment, and the high-dose compound K ointment could significantly reduce the thickness of the lesioned skin of model mice starting from the fourth day of treatment; the low-dose compound K ointment could significantly and effectively reduce the scales at the lesioned skin site of model mice starting from the fourth day of treatment; the low-dose compound K ointment could improve the total PASI score of the mouse model starting from the third day of treatment, the medium-dose compound K ointment could improve the total PASI score of the mouse model starting from the fourth day of treatment, and the high-dose compound K ointment could improve the total PASI score of the mouse model starting from the fifth day of treatment; the above results indicate that all three doses of compound K ointment can improve the symptoms of psoriasis lesions, and the low dose (0.12 g of crude drug / g of ointment) has a better therapeutic effect.

[0112] Table 3 Grouping of animals and drug application amounts of compound B ointment (indigo naturalis: lithospermum erythrorhizon: sophora flavescens = 5:2:2)

[0113] Table 4 Grouping of animals and drug application amounts of the orthogonal test (the amount of crude drug is 0.24 g / g of ointment)

[0114] Table 5 Grouping of animals of compound K ointment (indigo naturalis: lithospermum erythrorhizon: sophora flavescens = 5:1:3)

[0115] Example 4 The effective monomer component raw materials of Example 4 include: matrine oxide 1.17 mg / g of ointment, shikonin 0.033 mg / g of ointment, indigo 0.59 mg / g of ointment, and indirubin 0.026 mg / g of ointment.

[0116] The effective monomer components contained in the topical drug of Example 4 can be mixed with a matrix carrier (such as beeswax) to form an emulsion, gel, ointment, cream, patch, liniment, aerosol, spray, lotion, milk, paste, foam or drop, in the form of a single or multiple doses.

[0117] The monomer compounds in Example 4 were prepared according to the mass ratio with camellia oil / beeswax (25:4, g / g) to obtain an ointment in sequence.

[0118] Test Example 4 (1) Based on the three medicinal materials in compound A, taking the maximum extraction efficiency of each medicinal material as the basis, the maximum extraction content of its effective active components was taken in this Test Example 4, and the corresponding monomer compound ointment was prepared according to the requirements of Example 3.

[0119] Forty male BALB / c mice, 6 - 8 weeks old with standard body weight, were randomly divided into 6 groups, including a normal control group, a model group, an oxymatrine ointment group (1.17 mg / g ointment), a shikonin ointment group (0.033 mg / g ointment), an indigo ointment group (0.59 mg / g ointment), and an indirubin ointment group (0.026 mg / g ointment). One day before modeling, a hair clipper was used to remove the hair on the back of the mice, and then depilatory cream was used to completely remove the hair, with an area of 2×5 cm 2 . In the normal control group, vaseline was applied to the back. In other groups, imiquimod cream was evenly applied to establish a psoriasis model, 62.5 mg per mouse per day for 10 consecutive days. Among them, starting from the sixth day of modeling, imiquimod cream was applied in the morning for modeling, and 100 mg of the test ointment was applied in the afternoon. The normal control group was given the ointment base. The grouping and drug dosage of the pharmacodynamic tests of different monomer compound ointments are shown in Table 6. During the modeling and treatment periods, the skin lesions of the mice were photographed before drug administration for PASI scoring.

[0120] (2)Based on the pharmacodynamic results in experiment (1), an oxymatrine / indigo paired combination ointment was used for further verification of pharmacodynamic treatment.

[0121] Forty male BALB / c mice, 6 - 8 weeks old with standard body weight, were randomly divided into 6 groups, including a normal control group, a model group, a compound a ointment group (0.24 g of crude drug / g ointment), an oxymatrine ointment group (1.17 mg / g ointment), an indigo ointment group (0.59 mg / g ointment), and an oxymatrine / indigo ointment group (oxymatrine: 1.17 mg / g ointment, indigo 0.59 mg / g ointment). One day before modeling, a hair clipper was used to remove the hair on the back of the mice, and then depilatory cream was used to completely remove the hair, with an area of 2×5 cm 2 . In the normal control group, vaseline was applied to the back. In other groups, imiquimod cream was evenly applied to establish a psoriasis model, 62.5 mg per mouse per day for 10 consecutive days. Among them, starting from the sixth day of modeling, imiquimod cream was applied in the morning for modeling, and 100 mg of the test ointment was applied in the afternoon. The normal control group was given the ointment base. The grouping and drug dosage of the pharmacodynamic tests of the monomer composition ointment are shown in Table 7. During the modeling and treatment periods, the skin lesions of the mice were photographed before drug administration for PASI scoring.

[0122] PASI scoring criteria: 0 (none): There are no visible erythema or scales on the skin surface, and the skin lesions are equivalent to normal healthy skin.

[0123] 1 (low level): The skin lesions are partially covered with scales, mainly small pieces of dandruff. The skin lesions are slightly more advanced than normal skin and are light red.

[0124] 2 (Moderate): Most of the skin is partially or completely covered with scales, with moderate ridges, and the edges of the plaques are red, round or beveled.

[0125] 3 (Severe): Almost the entire surface of the skin lesion is covered with thick laminated scales, the skin lesion is thick, dark red, and has obvious elevations.

[0126] 4 (Extremely severe): The entire surface of the skin lesion is covered with very thick laminated scales, the skin lesion is very thick, extremely red in color, and has extremely obvious ribbing.

[0127] Total score: The sum of the scores for skin erythema, thickness, and scales.

[0128] Experimental results: (1) As Figure 7 shown, compared with the model group, the indigo ointment group could significantly reduce the erythema score at the skin lesion site of model mice on the fifth day of treatment; the shikonin ointment group could significantly reduce the thickness of the diseased skin of model mice starting from the second day of treatment, and the oxymatrine ointment group and indirubin ointment group could significantly reduce the thickness of the diseased skin of model mice starting from the third day of treatment; the indigo ointment group could significantly reduce the scales at the skin lesion site of model mice on the fifth day of treatment; the shikonin ointment group and indigo ointment group could improve the total PASI score of the mouse model starting from the third day of treatment.

[0129] (2) As Figure 8 shown, compared with the model group, the compound a ointment group and the oxymatrine / indigo ointment group could significantly reduce the erythema score at the skin lesion site of model mice starting from the third day of treatment, and the indigo ointment group could significantly reduce the erythema score at the skin lesion site of model mice on the sixth day of treatment; the compound a ointment group, oxymatrine ointment group, and oxymatrine / indigo ointment group could significantly reduce the thickness of the diseased skin of model mice starting from the fourth day of treatment; the oxymatrine / indigo ointment group could significantly reduce the scales at the skin lesion site of model mice on the fourth day of treatment; the oxymatrine / indigo ointment group could improve the total PASI score of the mouse model starting from the third day of treatment, and the compound a ointment group and oxymatrine ointment group could improve the total PASI score of the mouse model starting from the fourth day of treatment.

[0130] Table 6 Grouping and drug dosages of monomer composition ointments in the treatment of psoriasis mouse models

[0131] Table 7 Grouping and drug dosages of the pharmacodynamic tests of monomer composition ointments

[0132] The pharmacodynamic results show that the present invention can effectively reduce the clinical treatment indicators of psoriasis and has a significant therapeutic effect on the skin lesion sites of psoriasis mouse models.

[0133] In addition, the results of the efficacy experiments of the three medicinal materials in different proportions show that, as shown in Table 8, when the effective active ingredients indigo 0.0023 - 0.0182 mg / cm 2 , indirubin 0.0005 - 0.0662 mg / cm 2 , shikonin 0.00004 - 0.0038 mg / cm 2 and oxymatrine 0.0016 - 0.1138 mg / cm 2 are administered in the test ointment, they can all effectively reduce the erythema score of the psoriasis mouse model; when the effective active ingredients indigo 0.0009 - 0.0178 mg / cm 2 , indirubin 0.0005 - 0.0662 mg / cm 2 , shikonin 0.00001 - 0.0117 mg / cm 2 and oxymatrine 0.0003 - 0.1138 mg / cm 2 are administered in the test ointment, they can all effectively reduce the skin thickness score of the psoriasis mouse model; when the effective active ingredients indigo 0.001 - 0.0178 mg / cm 2 , indirubin 0.0005 - 0.016 mg / cm 2 , shikonin 0.00001 - 0.00411 mg / cm 2 and oxymatrine 0.0003 - 0.1084 mg / cm 2 are administered in the test ointment, they can all effectively reduce the scale score of the psoriasis mouse model; when the effective active ingredients indigo 0.0009 - 0.0182 mg / cm 2 , indirubin 0.0005 - 0.0662 mg / cm 2 , shikonin 0.00001 - 0.0117 mg / cm 2 and oxymatrine 0.0003 - 0.1138 mg / cm 2 are administered in the test ointment, they can all effectively reduce the total PASI score of the psoriasis mouse model.

[0134] Table 8 Dosages of the effective main components in the compound a-k, monomer and monomer-paired ointments

[0135] Based on the theory of traditional Chinese medicine, the present invention adopts the theory of syndrome differentiation and treatment, and formulates the prescription according to the pathogenesis of skin diseases. Each component can coordinate and promote each other. The above experimental results show that the traditional Chinese medicine compound preparation provided by the present invention has good synergistic effects, and no adverse reactions were observed during the experiment, and it has high safety.

[0136] The present invention measures the content of the effective components of a traditional Chinese medicine composition for treating psoriasis. The instruments, main compounds, reagents and specific measurement methods are as follows: 1. Instruments, main compounds and reagents.

[0137] 1.1 Instruments: Agilent 6470B triple quadrupole mass spectrometer LC / TQ; ultrasonic cleaner (Soner220H, R℃KER); SECURA125-1S electronic analytical balance (sartorius, d = 0.01mg); pure water instrument (Milli-pore, model: IQ-7015); high-speed centrifuge (eppendorf, model: 5425R).

[0138] 1.2 Main compounds and reagents: Indigo (CAS: 482-89-3, batch number MUST-21081304, purity > 98%), indirubin (CAS: 479-41-4, batch number MUST-21031611, purity > 98%), shikonin (CAS: 517-89-5, batch number MUST-20102111, purity > 98%), oxymatrine (CAS: 16837-52-8, batch number MUST-21080910, purity > 98%), purchased from Chengdu Mansite Biotechnology Co., Ltd.

[0139] Acetonitrile is chromatographically pure (Honeywell), formic acid is chromatographically pure (VWR), N,N-dimethylformamide is analytically pure (DUKSAN), ammonium acetate is bioanalytically pure (Sigma-Aldrich), concentrated ammonia water is ACS grade (Honeywell), methanol is chromatographically pure (RCILabscan), and self-made ultrapure water.

[0140] 2. Measurement method.

[0141] 2.1 Preparation of sample test solution: Accurately weigh appropriate amounts of the compound a-k test samples respectively, dissolve them in N,N-dimethylformamide and dilute with methanol, shake well to obtain test solutions with different concentration gradients.

[0142] 2.2 Preparation of reference solution: Weigh appropriate amounts of indigo, indirubin, shikonin, and oxymatrine reference substances accurately, dissolve them in N,N-dimethylformamide and dilute with methanol, then shake well to obtain reference substance solutions with indigo concentrations of 2.207 μg / ml, 1.104 μg / ml, 0.5518 μg / ml, 0.2759 μg / ml, indirubin concentrations of 4.883 μg / ml, 2.441 μg / ml, 1.2207 μg / ml, 0.6104 μg / ml, shikonin concentrations of 2.000 μg / ml, 0.400 μg / ml, 0.080 μg / ml, 0.016 μg / ml, 0.0328 μg / ml, 0.0064 μg / ml, and oxymatrine concentrations of 2.2773 μg / ml, 1.3867 μg / ml, 0.6934 μg / ml, 0.3467 μg / ml respectively.

[0143] 2.3 Determination method: Use ultra-high performance liquid chromatography-triple quadrupole tandem mass spectrometry (UPLC-QqQ-MS / MS) method. Precisely pipette the reference substance solution and the test sample solution respectively, inject them into the analytical instrument, and determine to obtain the results.

[0144] Determination method for the content of oxymatrine: Chromatographic conditions: Use an Agilent ZORBAX Eclipse Plus C18 column (2.1×5 mm, 1.8 µm) as the pre-column and an Agilent ZORBAX Eclipse Plus C18 column (2.1×100 mm, 1.8 µm) as the chromatographic column for separation. Flow rate: 0.4 mL / min, column temperature: 40 °C, injection volume: 1 μL. Gradient elution conditions: Mobile phase A is 0.01 mol / L ammonium acetate-aqueous solution (adjust the pH value to 8.0 with ammonia water), and mobile phase B is acetonitrile. 0 - 10 min, 5% - 80% B; 10.0 - 10.1 min, 80% - 100% B; 10.1 - 13 min, 100% B; 13 - 14 min, 100% - 5% B.

[0145] Mass spectrometry parameter conditions: Use the ESI mode for detection, and the scanning mode uses the multiple reaction monitoring mode (MRM). Use the following parameters: Dry gas temperature: 350 °C, dry gas flow rate: 10 L / min, nebulizing gas pressure: 45 psi, nitrogen is used as the spray assist gas, sheath gas temperature: 350 °C, sheath gas flow rate: 8 L / min, capillary voltage: 4000 V (positive mode). Precursor ion / product ion (m / z) of the component (oxymatrine): 265.2 / 247.1; collision energy (CE): 29 V.

[0146] Determination method for the content of indigo, indirubin, and shikonin: Using ultra-high performance liquid chromatography-triple quadrupole tandem mass spectrometry (UPLC-QqQ-MS / MS) method, with an Agilent ZORBAX Eclipse Plus C18 column (2.1×5 mm, 1.8 µm) as the pre-column and an Agilent ZORBAX Eclipse Plus C18 column (2.1×100 mm, 1.8 µm) as the chromatographic column for separation. Flow rate: 0.4 mL / min; column temperature: 40 °C, injection volume: 1 μL. Gradient elution conditions: mobile phase A is 0.1% formic acid-aqueous solution, and mobile phase B is 0.1% formic acid-acetonitrile. 0 - 10 min, 5% - 80% B; 10.0 - 10.1 min, 80% - 100% B; 10.1 - 13 min, 100% B; 13 - 14 min, 100% - 5% B.

[0147] Mass spectrometry parameter conditions: Detection was carried out using the ESI mode, and the scanning mode was the multiple reaction monitoring mode (MRM). The following parameters were used: Dry gas temperature: 350 °C, dry gas flow rate: 10 L / min, nebulizing gas pressure: 45 psi, nitrogen as the spray assist gas, sheath gas temperature: 350 °C, sheath gas flow rate: 8 L / min, capillary voltage: 4000 V (positive mode). Precursor ion / product ion (m / z) of each component (indigo, indirubin, and shikonin): 263.1 / 77.1, 263.1 / 219.1, and 287.1 / 218.0; collision energy (CE): 29 V, 29 V, and 13 V.

[0148] The determination method in the above step S2.3 includes the determination of linear relationship: accurately pipette the reference solution, dilute it step by step to obtain a series of solutions with different dilution multiples, measure them respectively under the test conditions, record the chromatographic peak areas of the 4 chemical components, use the reference substance mass concentration as the abscissa (X) and the peak area as the ordinate (Y) to plot the standard curve, and perform linear regression to obtain the standard curve equation. The linear equations, correlation coefficients, and linear ranges of the 4 chemical components in the present invention are shown in Table 9.

[0149] 3. Experimental results: As shown in the chromatographic peak diagram of the 4 chemical components in the reference solution in Figure 9 and the content detection results shown in Table 10, the 4 chemical components measured in the present invention can be effectively separated under the gradient elution conditions of this system. The method has a short analysis cycle and high separation efficiency. The mass spectrometry has high sensitivity and strong selectivity, and can accurately give the mass number information while accurately measuring the component content, achieving the effect of identifying compounds. The present invention conducts quantitative analysis on 4 different types of compounds in the compound prescription, with fast operation, good repeatability, accurate and reliable results, and can provide a basis for the overall quality control of the present invention.Figure 10 It is the chemical structural formula diagram of 4 components to be measured in the test sample solution of the present invention.

[0150] Table 9 Linear equations, correlation coefficients and linear ranges of 4 chemical components in the present invention

[0151] Table 10 Results of determination of extract content

[0152] The preferred embodiments of the present invention have been described in detail above. However, the present invention is not limited to the specific details in the above embodiments. Within the scope of the technical concept of the present invention, various simple modifications can be made to the technical solutions of the present invention. These simple modifications all fall within the protection scope of the present invention.

[0153] In addition, it should be noted that, in the case of no contradiction, the various specific technical features described in the above specific embodiments can be combined in any way. To avoid unnecessary repetition, the present invention will not separately describe various possible combination methods.

[0154] In addition, any combination can be made between various different embodiments of the present invention, as long as it does not violate the idea of the present invention, and it should also be regarded as the content disclosed by the present invention.

Claims

1. A Chinese medicine composition for treating psoriasis, characterized in that: The invention is prepared from the following Chinese medicinal raw materials by weight: 10-20 parts of indigo, 3-8 parts of lithospermum, 8-12 parts of coptis, 3-8 parts of curcuma, and 200-300 parts of camellia oil; or 200-300 parts of indigo, 80-120 parts of lithospermum powder, 80-120 parts of sophora flavescens powder, and 1000-1500 parts of camellia oil; or 10-80 parts of indigo, 8-70 parts of lithospermum, and 12-80 parts of sophora flavescens powder.

2. The Chinese medicine composition for treating psoriasis according to claim 1, characterized in that: The invention is prepared from the following Chinese medicinal raw materials by weight: 15 parts of Indigo Naturalis, 5 parts of Lithospermum Officinale, 10 parts of Coptis Chinensis, 5 parts of Curcuma Atractylodes, and 250 parts of Camellia Oil.

3. The Chinese medicine composition for treating psoriasis according to claim 1, characterized in that: The invention is prepared from the following Chinese medicinal raw materials by weight: 250 parts of indigo naturalis, 100 parts of lithospermum officinale, 100 parts of sophora flavescens and 1250 parts of camellia oil.

4. The Chinese medicine composition for treating psoriasis according to claim 1, characterized in that: The method is prepared from the following Chinese medicinal raw materials by weight: 16-56 parts of Indigo Naturalis, 11-50 parts of Lithospermum Officinale, and 16-50 parts of Sophora flavescens.

5. The Chinese medicinal composition for treating psoriasis according to any one of claims 1 to 4, characterized in that: Among the Chinese medicinal raw materials, Indigo uses Indigo powder, Lithospermum erythrorhizon uses Lithospermum erythrorhizon oil, Coptis chinensis uses Coptis chinensis powder, Curcuma atractylodes uses Curcuma atractylodes oil, or Sophora flavescens uses Sophora flavescens powder.

6. The Chinese medicine composition for treating psoriasis according to claim 5, characterized in that: The Chinese medicinal raw materials include 15 parts of indigo powder, 5 parts of lithospermum officinale oil, 10 parts of chuanxiong powder, 5 parts of zedoaria oil and 250 parts of camellia oil.

7. The Chinese medicine composition for treating psoriasis according to claim 5, characterized in that: The Chinese medicinal raw materials include 250 parts of indigo powder, 100 parts of lithospermum officinale powder and 100 parts of sophora flavescens powder, which are soaked in 1250 parts of camellia oil and then centrifuged to obtain effective ingredients in the supernatant to obtain an extract.

8. The Chinese medicine composition for treating psoriasis according to claim 5, characterized in that: 16-50 parts of Indigo naturalis powder, 10-50 parts of Lithospermum officinale powder, and 10-50 parts of Sophora flavescens powder are added with anhydrous ethanol at a liquid-to-solid ratio of 15 mL / g, and refluxed at 80°C for 2 h. The extraction is repeated 3 times, the supernatants are combined, the ethanol is recovered, and the extract is obtained by concentration and reduced pressure drying.

9. The Chinese medicinal composition for treating psoriasis according to any one of claims 1 to 6, characterized in that: The Chinese medicine composition is mixed with a matrix carrier commonly used in pharmacy to form an emulsion, gel, ointment, cream, patch, liniment, aerosol, spray, lotion, serum, paste, foam or drop; or the product extracted from Indigo Naturalis, Lithospermum Officinale and Sophora Flavescentis is formulated into a dosage form for local administration; or the product extracted from Indigo Naturalis, Lithospermum Officinale and Sophora Flavescentis through oil or ethanol is mixed with one or more additives selected from the following: hydrocarbons, waxes, preservatives, antioxidants, surfactants, absorption enhancers, stabilizers, gelling agents, active agents, odor absorbers or fragrances.

10. The Chinese medicine composition for treating psoriasis according to claim 9, characterized in that: The invention discloses an extract of a traditional Chinese medicine composition for treating skin diseases, which is extracted from Indigo Naturalis, Lithospermum Officinale and Sophora flavescens through oil or ethanol respectively. The extract of the traditional Chinese medicine composition for treating skin diseases comprises indigo, indirubin, shikonin and oxymatrine as effective active ingredients.

11. The Chinese medicine composition for treating psoriasis according to claim 10, characterized in that: It includes effective active ingredients: indigo 0.0009~0.0182mg / cm 2 , indigo carmine 0.0005~0.0662mg / cm 2 , shikonin 0.00001~0.0117mg / cm 2 and oxymatrine 0.0003~0.1138mg / cm 2 The active ingredients all effectively reduced the PASI total score of the psoriasis mouse model.

12. The Chinese medicine composition for treating psoriasis according to claim 10, characterized in that: It includes effective active ingredients: indigo 0.0023~0.0182mg / cm 2 , indigo carmine 0.0005~0.0662mg / cm 2 , shikonin 0.00004~0.0038mg / cm 2 and oxymatrine 0.0016~0.1138mg / cm 2 The active ingredients all effectively reduced the total erythema score of the psoriasis mouse model.

13. The Chinese medicine composition for treating psoriasis according to claim 10, characterized in that: It includes effective active ingredients: indigo 0.0009~0.0178mg / cm 2 , indigo carmine 0.0005~0.0662mg / cm 2 , shikonin 0.00001~0.0117mg / cm 2 and oxymatrine 0.0003~0.1138mg / cm 2 The active ingredients all effectively reduced the skin thickness score of the psoriasis mouse model.

14. The Chinese medicine composition for treating psoriasis according to claim 10, characterized in that: It includes effective active ingredients: indigo 0.001~0.0178mg / cm 2 , indigo carmine 0.0005~0.016mg / cm 2 , shikonin 0.00001~0.00411mg / cm 2 and oxymatrine 0.0003~0.1084mg / cm 2 The active ingredients all effectively reduced the total scale score of the psoriasis mouse model.

15. Use of the traditional Chinese medicine composition for treating psoriasis according to any one of claims 1 to 14 as an external medicine for treating psoriasis.

16. The use of the external medicine for treating psoriasis according to claim 15, characterized in that: The Chinese medicine composition for treating psoriasis is prepared into a pharmaceutically acceptable external preparation and applied to the affected skin area.

17. A method for preparing a Chinese medicine composition for treating psoriasis according to any one of claims 1 to 4, characterized in that: The following steps are involved: Step S1: using a mechanical steel grinder to grind the Chinese medicine raw material into fine powder, passing through a 100-mesh sieve to obtain a fine powder mixture for later use; Step S2: weighing, weighing the Chinese medicine raw materials in step S1 according to the mass fraction, and stirring evenly; Step S3: extracting the effective ingredients, extracting the fine powder mixture described in step S2 with oil or ethanol to obtain the effective ingredients of the traditional Chinese medicine composition.

18. The method for preparing the Chinese medicine composition for treating psoriasis according to claim 17, characterized in that: The step S3 of extracting the effective ingredients is to soak the fine powder mixture obtained in step S2 in oil for more than 10 days at a temperature of 20-25° C., and then centrifuge to obtain the effective ingredients in the supernatant.

19. The method for preparing the Chinese medicine composition for treating psoriasis according to claim 17, characterized in that: In step S3, anhydrous ethanol is added at a liquid-to-solid ratio of 5-25 mL / g, and reflux extraction is performed at a temperature of 70-100° C. for 1-3 h. The extraction is repeated 1-3 times, the supernatants are combined, the ethanol is recovered, and the active ingredients in the traditional Chinese medicine composition are obtained by concentration and reduced pressure drying.

20. A method for preparing a traditional Chinese medicine composition for treating psoriasis, characterized in that: The Chinese medicine composition for treating psoriasis according to any one of claims 1 to 4 comprises a mixture of an oil or ethanol extraction product containing Indigo Naturalis, Lithospermum Officinale and Sophora flavescens and one or more additives selected from the following: hydrocarbons, waxes, preservatives, antioxidants, surfactants, absorption enhancers, stabilizers, gelling agents, active agents, odor absorbers or spices; wherein the oil or ethanol extraction product containing Indigo Naturalis, Lithospermum Officinale and Sophora flavescens is prepared by a method comprising the following steps: Indigo naturalis, lithospermum officinale and sophora flavescens are extracted with oil at a temperature of 20-25°C to obtain crude products of Indigo naturalis, lithospermum officinale and sophora flavescens extracted with oil; Indigo naturalis, lithospermum officinale and sophora flavescens are extracted with ethanol at a heating temperature of 80°C to obtain crude products of Indigo naturalis, lithospermum officinale and sophora flavescens extracted with ethanol.

21. The preparation method according to claim 20, characterized in that: The hydrocarbon compound is selected from petroleum jelly, white vaseline or a combination thereof.

22. The preparation method according to claim 20, characterized in that: The wax is selected from beeswax, paraffin wax, yellow wax or a combination thereof.

23. A use of an external medicine for treating psoriasis, wherein the external medicine for treating psoriasis is derived from Indigo Naturalis or an extract of an indigo-producing plant or an indigo-producing extract used for external treatment of skin diseases, and the Indigo Naturalis or an indigo-producing plant extract or an indigo-producing extract is used for external treatment of skin diseases.

Images