Traditional chinese medicine composition for treatment of psoriasis, preparation method therefor, and use thereof

Abstract

Provided are a traditional Chinese medicine composition for the treatment of psoriasis, a preparation method therefor, and use thereof. In the traditional Chinese medicine composition, indigo naturalis and Lithospermum erythrorhizon compose a basic formula, camellia oil is used as supplement, and coptis chinensis, rhizoma curcumae, or radix sophorae flavescentis are respectively added in different formulas. By means of extracting effective components of indigo naturalis, Lithospermum erythrorhizon, and radix sophorae flavescentis, the traditional Chinese medicine composition can be prepared into a medicament for external use in treating skin diseases and can effectively treat psoriasis.

Description

A traditional Chinese medicine composition for treating psoriasis, and its preparation method and use Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and particularly 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, currently accounting for nearly 2,000 disorders; and dermatological diseases have the highest incidence rate. Data shows that approximately 150 million people in my country suffer from skin diseases each year, with the incidence rate exceeding 80% in southern my country. In hot and humid regions such as the Yellow River and Yangtze River basins, as well as in the subtropics, the Middle East, Europe, and the Americas, the vast majority of people suffer from varying degrees of psoriasis and pruritus, afflicting millions of people. While skin diseases vary regionally and seasonally, they are, by and large, a global problem.

[0003] Psoriasis, commonly known as psoriasis, is an immune-mediated, hereditary, chronic skin disease that manifests on the skin, joints, or both. Due to its significant impact on physical appearance, it can provoke negative reactions from others, adding an immeasurable psychological burden to patients. Compared to a range of other chronic conditions, 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. The prevalence of psoriasis is approximately 2% in Europe and North America, while it ranges from 0.1% to 0.5% in Asian populations. Patients with psoriasis are at increased risk for other chronic and serious health conditions, including psoriatic arthritis, metabolic syndrome or its components, cardiovascular disease, and other conditions such as anxiety and depression, non-alcoholic fatty liver disease, Crohn's disease, and lymphoma. Psoriatic arthritis is the most serious complication. Current treatments for psoriasis primarily target a single pathogenic factor or mechanism, but these have limitations in both efficacy and adverse reactions, falling far short of ideal therapeutic outcomes. 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, a preparation method thereof and use thereof

[0005] 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 flavescens 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 flavescens powder.

[0006] Preferably, the traditional Chinese medicine composition for treating psoriasis is prepared from the following traditional Chinese medicine raw materials in parts by mass: 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.

[0007] Preferably, the traditional Chinese medicine composition for treating psoriasis is made from the following traditional Chinese medicine raw materials in parts by mass: 250 parts of Indigo Naturalis, 100 parts of Lithospermum Officinale, 100 parts of Sophora flavescens, and 1250 parts of Camellia oil.

[0008] Preferably, the traditional Chinese medicine composition for treating psoriasis is prepared from the following traditional Chinese medicine raw materials in parts by mass: 16-56 parts of Indigo Naturalis, 11-50 parts of Lithospermum Officinale, and 16-50 parts of Sophora flavescens.

[0009] Furthermore, among the Chinese medicinal raw materials, Indigo naturalis uses Indigo naturalis 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.

[0010] More preferably, the Chinese medicinal raw materials include 15 parts of Indigo Naturalis powder, 5 parts of Lithospermum officinale oil, 10 parts of Coptis chinensis powder, 5 parts of Curcuma oil, and 250 parts of Camellia oil.

[0011] More preferably, among the Chinese medicinal raw materials, 250 parts of indigo powder, 100 parts of lithospermum officinale powder, and 100 parts of sophora flavescens powder are soaked in 1250 parts of camellia oil and then centrifuged to obtain the effective ingredients in the supernatant to obtain an extract.

[0012] More preferably, 16 to 50 parts of indigo powder, 10 to 50 parts of lithospermum powder, and 10 to 50 parts of sophora flavescens powder are added with anhydrous ethanol at a liquid-to-material ratio of 15 mL / g, and refluxed at 80°C for 2 hours. The extraction is repeated 3 times, the supernatants are combined, the ethanol is recovered, and the extract is obtained by concentration and drying under reduced pressure.

[0013] Furthermore, the Chinese medicine composition is mixed with a matrix carrier commonly used in medicine 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 Flavor is formulated into a dosage form for topical administration; or the product extracted from Indigo Naturalis, Lithospermum Officinale and Sophora Flavor 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 spices.

[0014] Additionally, the Chinese herbal composition for treating psoriasis is an extract of an external Chinese herbal 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 external Chinese herbal composition contains indigo, indirubin, shikonin and oxymatrine as effective active ingredients.

[0015] On the other hand, the Chinese medicine composition for treating psoriasis comprises the following effective active ingredients: indigo 0.0009-0.0182 mg / cm 2 , indirubin 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.

[0016] On the other hand, the Chinese medicine composition for treating psoriasis comprises the following effective active ingredients: indigo 0.0023-0.0182 mg / cm 2 , indirubin 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 erythema score of the psoriasis mouse model.

[0017] On the other hand, the Chinese medicine composition for treating psoriasis comprises the following effective active ingredients: indigo 0.0009-0.0178 mg / cm 2 , indirubin 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.

[0018] On the other hand, the Chinese medicine composition for treating psoriasis comprises the following effective active ingredients: indigo 0.001-0.0178 mg / cm 2 , indirubin 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 scaling score of the psoriasis mouse model.

[0019] According to a second aspect of the technical solution of the present invention, there is provided a use of any of the above-mentioned traditional Chinese medicine compositions for treating psoriasis as an external medicine for treating psoriasis.

[0020] Furthermore, the Chinese medicine composition for treating psoriasis is prepared into a pharmaceutically acceptable external preparation and applied to the affected skin area.

[0021] According to a third aspect of the technical solution of the present invention, a method for preparing a traditional Chinese medicine composition for treating psoriasis is provided, comprising the following steps:

[0022] Step S1: using a mechanical steel grinder to finely grind the Chinese medicine raw material into a fine powder, passing it through a 100-mesh sieve to obtain a fine powder mixture for later use;

[0023] Step S2: Weigh the Chinese medicinal raw materials obtained in step S1 according to the mass fraction and stir them evenly;

[0024] Step S3: Extracting the active ingredients: extracting the fine powder mixture described in step S2 with oil or ethanol to obtain the active ingredients of the traditional Chinese medicine composition.

[0025] Furthermore, the step S3 of extracting the active ingredient comprises soaking the fine powder mixture obtained in step S2 in oil at a temperature of 20-25° C. for more than 10 days, and then centrifuging to obtain the active ingredient in the supernatant.

[0026] Furthermore, in step S3, anhydrous ethanol is added at a liquid-to-solid ratio of 5 to 25 mL / g and reflux extraction is carried out at a temperature of 70 to 100° C. for 1 to 3 hours. The extraction is repeated 1 to 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 drying under reduced pressure.

[0027] According to a fourth aspect of the technical solution of the present invention, a method for preparing a traditional Chinese medicine composition for treating psoriasis is provided, wherein the method comprises mixing an oil or ethanol extraction product containing Indigo Naturalis, Lithospermum Officinale and Sophora Flavescens with 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:

[0028] Indigo naturalis, lithospermum erythrorhizon and Sophora flavescens are extracted with oil at a temperature of 20-25°C to obtain crude products of Indigo naturalis, lithospermum erythrorhizon and Sophora flavescens extracted with oil; Indigo naturalis, lithospermum erythrorhizon and Sophora flavescens are extracted with ethanol at a heating temperature of 80°C to obtain crude products of Indigo naturalis, lithospermum erythrorhizon and Sophora flavescens extracted with ethanol.

[0029] Furthermore, the hydrocarbon is selected from petroleum jelly, white vaseline or a combination thereof.

[0030] Furthermore, the wax is selected from beeswax, paraffin wax, yellow wax or a combination thereof.

[0031] According to the fifth aspect of the technical solution of the present invention, a use of an external medicine for treating psoriasis is provided, wherein the external medicine for treating psoriasis is derived from Indigo Naturalis or an indigo-producing plant extract 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.

[0032] Compared with the prior art, the present invention has the following beneficial effects:

[0033] 1. This invention is a compound preparation containing traditional Chinese medicine ingredients and skin protection ingredients. Through the combined action of internal and external factors, the therapeutic effect is more comprehensive. It fundamentally alleviates the symptoms of skin patients. Its all-natural ingredients have low side effects and no hormone dependence.

[0034] 2. The present invention is based on a treatment experiment on a psoriasis mouse model induced by imiquimod cream, which confirms that the present invention has significant efficacy, can effectively reduce the PASI score, and promote the regression of skin lesions. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] Figure 1-1 shows the results of mouse pathological sections comparing normal mice, a model group, and a drug group in a test example of the present invention; Figures 1-1a and 1-1b show the results of mouse pathological sections of normal mice, Figures 1-1c and 1-1d show the results of mouse pathological sections of a model group, and Figures 1-1e and 1-1f show the results of mouse pathological sections of a retinoic acid-positive drug group; observations were made using a 10x microscope and a 20x microscope, respectively;

[0036] Figures 1-2 show the pathological sections of mice treated with the herbal moisturizing cream according to the test examples of the present invention; Figure 1-2a shows a pathological section of a mouse with normal keratinization in most cells and reduced acanthosis; Figure 1-2b shows a pathological section of a mouse with reduced inflammatory cell infiltration; and Figure 1-2c shows a pathological section of a mouse with hair follicles growing.

[0037] FIG2 is a schematic diagram showing the efficacy comparison results of different doses of Compound A ointment in treating psoriasis mouse models;

[0038] FIG3 shows the efficacy of medium-dose Compound A ointment in treating psoriasis mouse models;

[0039] FIG4 shows the efficacy of different doses of compound B ointment in treating psoriasis mouse models;

[0040] FIG5 shows the efficacy of compound bj ointment in treating psoriasis mouse model;

[0041] Figure 6: Efficacy results of different doses of compound K ointment in treating psoriasis mouse model;

[0042] FIG7 shows the efficacy of ointments of different monomeric compounds in treating psoriasis mouse models;

[0043] FIG8 shows the efficacy of the monomer composition ointment in treating a psoriasis mouse model;

[0044] FIG9 is a chromatogram of four chemical components in the reference solution of the present invention;

[0045] FIG10 is a diagram showing the chemical structural formulas of the four components to be tested in the test solution of the present invention. DETAILED DESCRIPTION

[0046] In order to make the technical problems solved by the present invention, the technical solutions adopted, and the beneficial effects obtained more clearly understood, the present invention is further described in detail below with reference to specific embodiments. The specific embodiments described herein are only used to illustrate the present invention and are not intended to constitute any limitation of 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.

[0047] The following specific examples are provided to help understand the present invention, but it should be understood that the embodiments and test examples listed in the present invention are only used to illustrate the present invention and do not constitute any limitation. The actual protection scope of the present invention is set forth in the claims.

[0048] The present invention provides a traditional Chinese medicine composition for treating psoriasis, and its preparation method and use, as follows:

[0049] Provided is a traditional Chinese medicine composition for treating psoriasis. The composition is prepared from the following traditional Chinese medicine raw materials, measured 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 zedoaria, 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 flavescens 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 flavescens powder.

[0050] Preferably, the traditional Chinese medicine composition for treating psoriasis is prepared from the following traditional Chinese medicine raw materials in parts by mass: 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.

[0051] Preferably, the traditional Chinese medicine composition for treating psoriasis is made from the following traditional Chinese medicine raw materials in parts by mass: 250 parts of Indigo Naturalis, 100 parts of Lithospermum Officinale, 100 parts of Sophora flavescens, and 1250 parts of Camellia oil.

[0052] Preferably, the traditional Chinese medicine composition for treating psoriasis is prepared from the following traditional Chinese medicine raw materials in parts by mass: 16-56 parts of Indigo Naturalis, 11-50 parts of Lithospermum Officinale, and 16-50 parts of Sophora flavescens.

[0053] Furthermore, among the Chinese medicinal raw materials, Indigo naturalis uses Indigo naturalis 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.

[0054] More preferably, the Chinese medicinal raw materials include 15 parts of Indigo Naturalis powder, 5 parts of Lithospermum officinale oil, 10 parts of Coptis chinensis powder, 5 parts of Curcuma oil, and 250 parts of Camellia oil.

[0055] More preferably, among the Chinese medicinal raw materials, 250 parts of indigo powder, 100 parts of lithospermum officinale powder, and 100 parts of sophora flavescens powder are soaked in 1250 parts of camellia oil and then centrifuged to obtain the effective ingredients in the supernatant to obtain an extract.

[0056] More preferably, 16 to 50 parts of indigo powder, 10 to 50 parts of lithospermum powder, and 10 to 50 parts of sophora flavescens powder are added with anhydrous ethanol at a liquid-to-material ratio of 15 mL / g, and refluxed at 80°C for 2 hours. The extraction is repeated 3 times, the supernatants are combined, the ethanol is recovered, and the extract is obtained by concentration and drying under reduced pressure.

[0057] Furthermore, the Chinese medicine composition is mixed with a matrix carrier commonly used in medicine 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 Flavor is formulated into a dosage form for topical administration; or the product extracted from Indigo Naturalis, Lithospermum Officinale and Sophora Flavor 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 spices.

[0058] Additionally, the Chinese herbal composition for treating psoriasis is an extract of an external Chinese herbal 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 external Chinese herbal composition contains indigo, indirubin, shikonin and oxymatrine as effective active ingredients.

[0059] On the other hand, the Chinese medicine composition for treating psoriasis comprises the following effective active ingredients: indigo 0.0009-0.0182 mg / cm 2 , indirubin 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.

[0060] On the other hand, the Chinese medicine composition for treating psoriasis comprises the following effective active ingredients: indigo 0.0023-0.0182 mg / cm 2 , indirubin 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 erythema score of the psoriasis mouse model.

[0061] On the other hand, the Chinese medicine composition for treating psoriasis comprises the following effective active ingredients: indigo 0.0009-0.0178 mg / cm 2 , indirubin 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.

[0062] On the other hand, the Chinese medicine composition for treating psoriasis comprises the following effective active ingredients: indigo 0.001-0.0178 mg / cm 2 , indirubin 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 scaling score of the psoriasis mouse model.

[0063] In another embodiment, a use of any of the above-mentioned traditional Chinese medicine compositions for treating psoriasis as an external medicine for treating psoriasis is provided.

[0064] Furthermore, the Chinese medicine composition for treating psoriasis is prepared into a pharmaceutically acceptable external preparation and applied to the affected skin area.

[0065] In another embodiment, a method for preparing a Chinese medicine composition for treating psoriasis is provided, comprising the following steps:

[0066] Step S1: using a mechanical steel grinder to finely grind the Chinese medicine raw material into a fine powder, passing it through a 100-mesh sieve to obtain a fine powder mixture for later use;

[0067] Step S2: Weigh the Chinese medicinal raw materials obtained in step S1 according to the mass fraction and stir them evenly;

[0068] Step S3: Extracting the active ingredients: extracting the fine powder mixture described in step S2 with oil or ethanol to obtain the active ingredients of the traditional Chinese medicine composition.

[0069] Furthermore, the step S3 of extracting the active ingredient comprises soaking the fine powder mixture obtained in step S2 in oil at a temperature of 20-25° C. for more than 10 days, and then centrifuging to obtain the active ingredient in the supernatant.

[0070] Furthermore, in step S3, anhydrous ethanol is added at a liquid-to-solid ratio of 5 to 25 mL / g and reflux extraction is carried out at a temperature of 70 to 100° C. for 1 to 3 hours. The extraction is repeated 1 to 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 drying under reduced pressure.

[0071] In another embodiment, a method for preparing a traditional Chinese medicine composition for treating psoriasis is provided, wherein the method comprises mixing an oil or ethanol extraction product containing Indigo Naturalis, Lithospermum Officinale, and Sophora Flavescens with one or more additives selected from the group consisting of hydrocarbons, waxes, preservatives, antioxidants, surfactants, absorption enhancers, stabilizers, gelling agents, active agents, odor absorbers, or fragrances according to any of the above traditional Chinese medicine compositions for treating psoriasis; wherein the oil or ethanol extraction product containing Indigo Naturalis, Lithospermum Officinale, and Sophora Flavescens is prepared by a method comprising the following steps:

[0072] Indigo naturalis, lithospermum erythrorhizon and Sophora flavescens are extracted with oil at a temperature of 20-25°C to obtain crude products of Indigo naturalis, lithospermum erythrorhizon and Sophora flavescens extracted with oil; Indigo naturalis, lithospermum erythrorhizon and Sophora flavescens are extracted with ethanol at a heating temperature of 80°C to obtain crude products of Indigo naturalis, lithospermum erythrorhizon and Sophora flavescens extracted with ethanol.

[0073] Furthermore, the hydrocarbon is selected from petroleum jelly, white vaseline or a combination thereof.

[0074] Furthermore, the wax is selected from beeswax, paraffin wax, yellow wax or a combination thereof.

[0075] According to the fifth aspect of the technical solution of the present invention, a use of an external medicine for treating psoriasis is provided, wherein the external medicine for treating psoriasis is derived from Indigo Naturalis or an indigo-producing plant extract 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.

[0076] The present invention is further described below in conjunction with the effects and effects of the Chinese medicine composition for treating psoriasis, its preparation method, and its use:

[0077] The present invention discloses a traditional Chinese medicine composition for treating psoriasis, which uses Indigo Naturalis and Lithospermum Officinale as a base formula, supplemented with camellia oil, and, in different combinations, adds Rhizoma Corydalis, Sophora flavescens, and Atractylodes Rhizoma Curcumae, respectively, to obtain traditional Chinese medicine compositions for treating psoriasis with different therapeutic effects. The present invention extracts effective ingredients from Rhizoma Corydalis and Atractylodes Rhizoma Curcumae to obtain Lithospermum Officinale oil and Atractylodes Rhizoma Curcumae oil, respectively. Indigo Naturalis, Rhizoma Corydalis, Sophora flavescens, and Lithospermum Officinale are ground to obtain Indigo Naturalis powder, Rhizoma Corydalis powder, Sophora flavescens powder, and Lithospermum Officinale powder, respectively. The ground powders and / or the extracted effective ingredients are combined according to mass fractions to obtain traditional Chinese medicine compositions for treating psoriasis with different therapeutic effects. Furthermore, the effective ingredients of Indigo Naturalis are extracted to obtain active ingredients such as indigo and indirubin, and the effective ingredients of Lithospermum Officinale and Sophora flavescens are extracted to obtain active ingredients such as shikonin and oxymatrine, respectively. Based on the obtained active ingredients, different ointments and pharmaceutically feasible dosage forms are combined to treat psoriasis.

[0078] In one embodiment, different combinations of effective active monomer components are extracted from each component, such as oxymatrine, shikonin, indigo, indirubin, etc., and oxymatrine-indigo pairings are combined to obtain different ointments and pharmaceutically feasible dosage forms; in another embodiment, the above active ingredient raw materials are mixed with a matrix carrier (such as beeswax) to form an emulsion, gel, ointment, cream, patch, liniment, aerosol, spray, lotion, serum, paste, foam or drops, in the form of single or multiple doses.

[0079] The Chinese medicine composition for treating psoriasis of the present invention can be used as an external Chinese medicine composition for treating skin diseases. The compound Chinese medicine composition or monomer components thereof can be mixed with a matrix carrier (such as beeswax) to form an emulsion, gel, ointment, cream, patch, liniment, aerosol, spray, lotion, serum, paste, foam or drops, in the form of single or multiple doses.

[0080] Furthermore, the extract of the external Chinese medicine composition for treating psoriasis of the present invention is a Chinese medicine composition for treating skin diseases extracted from Indigo Naturalis, Lithospermum officinale and Sophora flavescens respectively by oil or ethanol. The extract of the external Chinese medicine composition contains 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 Chinese medicine combination test ointment for treating psoriasis. For example, the Chinese medicine combination test ointment contains 0.0009 to 0.0182 mg / cm of the effective active ingredient indigo. 2 、Indirubin 0.0005~0.0662mg / cm 2 , shikonin 0.00001~0.0117mg / cm 2 and oxymatrine 0.0003~0.1138mg / cm 2 , which can effectively reduce the total PASI score of the psoriasis mouse model; the Chinese medicine combination ointment contains the active ingredient indigo 0.0023~0.0182mg / cm 2 、Indirubin 0.0005~0.0662mg / cm 2 , shikonin 0.00004~0.0038mg / cm 2 and oxymatrine 0.0016~0.1138mg / cm 2 , which can effectively reduce the erythema score of the psoriasis mouse model. The Chinese medicine combination ointment contains the active ingredient indigo 0.0009-0.0178 mg / cm 2 、Indirubin 0.0005~0.0662mg / cm 2 , shikonin 0.00001~0.0117mg / cm 2 and oxymatrine 0.0003~0.1138mg / cm 2, which can effectively reduce the skin thickness score of the psoriasis mouse model. The Chinese medicine combination ointment contains the active ingredient 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 , which can effectively reduce the scaling score of the psoriasis mouse model.

[0081] In another embodiment, oxymatrine alone can be mixed with a matrix carrier (e.g., beeswax) to form an ointment, cream, gel, liniment, or film, which can effectively reduce the skin thickness score in a psoriasis mouse model. Shikonin alone can effectively reduce the PASI total score and skin thickness score in a psoriasis mouse model, and indirubin alone can effectively reduce the skin thickness score in a psoriasis mouse model. The oxymatrine-indigo combination can effectively reduce the PASI total score, erythema score, skin thickness score, and scaling score in a psoriasis mouse model. In another embodiment, a traditional Chinese medicine composition for treating psoriasis comprises products extracted from Indigo Naturalis, Lithospermum Officinale and Sophora Flavoring, and is formulated into a dosage form for topical administration; it comprises 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 Flavoring 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 Flavoring powder.

[0082] The basic mechanism of traditional Chinese medicine of the present invention is as follows: psoriasis is caused by multiple factors such as deficiency of blood and nutrients, wind generated by blood deficiency, and malnutrition of the skin; or wind-heat accumulated in the skin, and wind generated by blood heat; malnutrition of the skin leads to repeated attacks, and the accumulation of heat over time will flow through the joints and block the meridians; in severe cases, internal toxins are raging, and both qi and blood are burning; scales and erythema are the main skin lesions, and the course of the disease is lingering and recurrent, and it is difficult to heal. Among the ingredients contained in the present invention, Indigo can be obtained from one or more indigo-containing plants, including Indigofera tinctoria, Indigofera tinctoria, Indigofera tinctoria, and Indigofera taiwanensis, which are salty and cold in nature, and have the effects of clearing away heat and detoxifying, cooling blood and eliminating spots, purging fire and calming the nerves, and can be used externally to detoxify, remove dampness, and reduce swelling and relieve pain; Lithospermum erythrorhizon is an important medicine for cooling blood, and has the effects of cooling blood, promoting blood circulation, detoxifying, clearing heat and relieving pain, and removing rot and promoting tissue regeneration; Coptis chinensis is bitter and very cold in taste, and can treat itchy sores, scabies, and ulcers. , there is excess evil heat, Chuanlian is a must-use; Curcuma zedoaria is warm in nature and bitter in taste, and has the effects of promoting blood circulation, removing blood stasis, eliminating accumulation and relieving pain; Sophora flavescens can cool blood, relieve heat and toxins, treat scabies, abscesses and sores, and treat skin itching, blood-wind tinea sores, and naughty white dandruff; Camellia oil is rich in natural vitamin E, tea polyphenols, and squalene, and has the effect of beauty and anti-aging; Beeswax tastes sweet and light, is neutral in nature, non-toxic, and has the functions of invigorating qi and nourishing blood, dispelling wind and moisturizing dryness, harmonizing blood and detoxifying.

[0083] The present invention is further illustrated below through a number of specific embodiments and test examples.

[0084] Example 1

[0085] The active ingredients of the tested ointment in Example 1 include: 15 parts of Indigo Naturalis, 5 parts of Lithospermum Officinale, 10 parts of Coptis chinensis powder, 5 parts of Curcuma Oil, and 250 parts of Camellia Oil.

[0086] The topical medicine containing the Chinese medicinal ingredients of Example 1 can be mixed with a matrix carrier (such as beeswax) to form an emulsion, gel, ointment, cream, patch, liniment, aerosol, spray, lotion, serum, paste, foam or drops in the form of single or multiple doses.

[0087] Test Example 1

[0088] 1.1 Safety test

[0089] Test method: Four standard New Zealand white rabbits weighing 1.80-2.20 kg were used. 24 hours before the test, the hair on both sides of the spine of the experimental animals was trimmed, and the hair removal area was 3×3 cm. 2 .

[0090] Apply 0.5 mL of the test substance to one side of the skin, covering an area of ​​2.5 × 2.5 cm 2The other side remained untreated as a control. Apply the product once daily for 14 consecutive days. Starting from the second day, trim the hair before each application and remove any residual test substance with pure water. Observe the results after one hour and score according to Table 1 of the Skin Irritation and Corrosion Test in the "Safety Technical Specifications for Cosmetics" (2015 edition). Treat the control and test areas identically.

[0091] Results: The skin irritation intensity of rabbits was determined according to Table 2 of the Skin Irritation and Corrosion Test in the "Safety Technical Specifications for Cosmetics" (2015 edition). The test was conducted to observe whether there were any other symptoms besides skin irritation.

[0092] Test results: By statistically integrating the skin irritation responses 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.

[0093] 1.2 Pharmacodynamic studies

[0094] Experimental method: 20 SPF C57 female mice, 7-8 weeks old and standard weight, were randomly divided into 4 groups, including normal control group, retinoic acid cream positive drug group, model group, and test ointment application group. The day before modeling, the back of the mice was shaved with a shaver, with an area of ​​about 2×3 cm. 2 . The normal control group was not given any drug, and the other groups were evenly smeared with imiquimod cream to create a psoriasis model, 20 mg / day per mouse, for 14 consecutive days. Starting from the fourth day of modeling, imiquimod cream was applied in the morning, and the positive drug or the test ointment was applied in the afternoon. The amount of the test ointment applied was enough to cover the psoriasis model area with a thickness of about 1 mm. Retinoic acid cream was administered once a day according to the instructions, and the normal control group did not receive any treatment. 24 hours after the last application, the mice were killed by cervical dislocation, and the skin tissue was taken. After formaldehyde fixation, tissue dehydration, embedding, sectioning, H&E staining, etc., the film was observed under a microscope.

[0095] Experimental Results: Figures 1-1a-1f show the pathological sections of mice compared to normal mice, a model group, and a drug group in the test examples of the present invention. Figures 1-1a and 1-1b show the pathological sections of normal mice, Figures 1-1c and 1-1d show the pathological sections of the model group, and Figures 1-1e and 1-1f show the pathological sections of mice in the retinoic acid-positive drug group. These images were observed using a 10x and 20x microscope, respectively. The pathological sections of normal mice shown in Figures 1-1a and 1-1b, and the pathological sections of the model group shown in Figures 1-1c and 1-1d, demonstrate: parakeratosis, infiltration of neutrophils and lymphocytes; thinning or disappearance of the granular layer; hypertrophy of the stratum acantholyticum; and acute inflammation. The pathological sections of mice in the retinoic acid-positive drug group shown in Figures 1-1e and 1-1f demonstrate: persistent parakeratosis, a very prominent granular layer; hypertrophy of the stratum acantholyticum; and reduced inflammatory cell infiltration.

[0096] Figures 1-2a-2c show the pathological sections of mice treated with the herbal moisturizing cream in the test examples of the present invention. Figure 1-2a shows a pathological section showing normal keratinization in most cells and reduced acanthosis; Figure 1-2b shows a pathological section showing reduced inflammatory cell infiltration; and Figure 1-2c shows a pathological section showing hair follicles growing. Figures 1-2a-2c show that most cells show normal keratinization and reduced acanthosis; inflammatory cell infiltration is reduced; and hair follicles grow. The following phenomena are also observed: 1. Pathological changes in the psoriasis mouse model, including parakeratinization, acanthosis, neutrophil and lymphocyte infiltration, and thinning or disappearance of the granular layer, are typical pathological manifestations of psoriasis; 2. Parakeratinization persists, acanthosis is thickened, the granular layer is very prominent, and inflammatory cell infiltration is reduced. 3. After using the herbal moisturizing cream for 11 days, pathological tissue observation showed that most of the cells had normal keratinization, acanthosis hypertrophy was reduced, inflammatory cell infiltration was significantly reduced, and hair follicles had grown hair.

[0097] Test Example 1 shows that compared to the normal group, the skin tissue of mice in the model group showed significant parakeratosis, neutrophil and lymphocyte infiltration, thinning or disappearance of the granular layer, acanthosis, acute inflammation, and other typical pathological manifestations of psoriasis. In the positive drug group, parakeratosis continued, but the granular layer became very prominent, the acanthosis was thickened, and the inflammatory cell infiltration was reduced. In the test ointment group, the majority of skin tissue cells showed normal keratinization, reduced acanthosis, reduced inflammatory cell infiltration, and hair follicles began to grow.

[0098] The pharmacodynamic results showed that the Chinese medicine composition ointment of Example 1 had a significant therapeutic effect on the psoriasis skin tissue of C57 mice.

[0099] Example 2

[0100] The effective ingredients of the traditional Chinese medicine composition are prepared according to the following steps.

[0101] Step S1: using a mechanical steel grinder to grind Indigo Naturalis, Lithospermum Officinale and Sophora flavescens into fine powder respectively, and passing through a 100-mesh sieve to obtain a fine powder mixture for later use;

[0102] Step S2: Weighing the Chinese medicinal raw materials of step S1 according to 250 parts of indigo powder, 100 parts of lithospermum powder, and 100 parts of sophora flavescens powder, and stirring evenly;

[0103] Step S3: 1250 parts of camellia oil, i.e., the mass ratio of Indigo Naturalis: Lithospermum Officinale: Sophora flavescens: camellia oil is 5:2:2:25, soaked at 20-25°C for 20 days, and then centrifuged to obtain the effective ingredients in the supernatant.

[0104] The active ingredients in Example 2 and beeswax were taken in a mass ratio of 25:4 to prepare compound a ointment.

[0105] Test Example 2

[0106] (1) 40 BALB / c male mice, 6-8 weeks old and of standard weight, were randomly divided into 6 groups, including a normal control group, a calcipotriol ointment positive drug group, a model group, and a low-, medium-, and high-dose compound a ointment group. The day before modeling, the back of the mice was shaved with a shaver and the hair was completely removed with a depilatory cream. The area was 2×5 cm. 2 The normal control group had petroleum jelly applied to their backs, while the other groups were uniformly applied with imiquimod cream to create a psoriasis model. Each mouse received 62.5 mg / day for 10 consecutive days. Starting on the fifth day of modeling, mice were given imiquimod cream in the morning and 50 mg of the positive drug or 50 mg, 100 mg, or 200 mg of the test ointment were applied in the afternoon. The normal control group received the ointment base. The grouping of the experimental animals and the drug dosages are shown in Table 1. During modeling and treatment, the skin lesions of the mice were photographed before drug administration and PASI scores were calculated.

[0107] (2) 40 BALB / c male mice, 6-8 weeks old and of standard 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 application group. The day before modeling, the back of the mice was shaved with a shaver and the hair was completely removed with a depilatory cream. The area was 2×5 cm. 2 The normal control group had petroleum jelly applied to their backs, while the other groups were uniformly treated with imiquimod cream to create a psoriasis model. Each mouse received 62.5 mg / day for 10 consecutive days. Starting on the sixth day of modeling, imiquimod cream was administered in the morning, followed by 50 mg of the active agent or 100 mg of Compound A ointment in the afternoon. The normal control group received the ointment base. The groupings of the experimental animals and the drug dosages are shown in Table 2. During modeling and treatment, the skin lesions of the mice were photographed before drug administration and PASI scores were calculated.

[0108] PASI score indicators:

[0109] 0 (none): No erythema or scales are visible on the skin surface, and the skin lesions are equivalent to normal healthy skin.

[0110] 1 (low grade): The lesions are partially covered with scales, mainly small pieces of dandruff. The lesions are slightly more advanced than normal skin and are light red.

[0111] 2 (Moderate): Most of the skin is partially or completely covered with scales with moderate ridges and red, rounded or beveled edges.

[0112] 3 (severe): Almost the entire surface of the lesion is covered with thick layered scales. The lesion is thick, dark red, and has obvious ridges.

[0113] 4 (extremely severe): The entire surface of the lesion is covered with thick layered scales. The lesion is very thick, very red in color, and has very obvious ridges.

[0114] Total score: the sum of the three scores of skin erythema, thickness and scaling.

[0115] Experimental results:

[0116] (1) As shown in Figure 2, the efficacy comparison results of different doses of Compound A ointment in treating psoriasis mouse models show that compared with the model group, 50mg, 100mg and 200mg of Compound A ointment can significantly reduce the erythema score of the lesion site of the model mice starting from the third day of treatment. 50mg, 100mg and 200mg of Compound A ointment can significantly reduce the thickness of the lesion skin of the model mice starting from the fourth day of treatment. 100mg and 200mg of Compound A can significantly and effectively reduce the scales of the lesion site of the model mice starting from the fourth day of treatment. The total PASI score of the mouse model can be improved 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 tested ointment is better than that of the classic topical anti-psoriatic drug vitamin D analogue - calcipotriol ointment.

[0117] Based on the above results, both 100 mg and 200 mg of compound a ointment can effectively improve the symptoms of psoriasis lesions, so the 100 mg dose was selected for further efficacy verification.

[0118] (2) As shown in Figure 3, compared with the model group, 100 mg of Compound A ointment can significantly reduce the erythema score of the lesion site of the model mice starting from the second day of treatment, significantly reduce the thickness of the lesion skin of the model mice starting from the third day of treatment, significantly and effectively reduce the scales of the lesion site of the model mice starting from the second day of treatment, and improve the PASI total 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 test ointment is more effective than the classic topical anti-psoriatic drug vitamin D analogue - calcipotriol ointment.

[0119] The above pharmacodynamic results show that the tested ointment of this example can effectively reduce the clinical treatment indicators of psoriasis, has a significant therapeutic effect on the skin lesions of the psoriasis mouse model, and helps to restore the weight of psoriasis mice.

[0120] Table 1 Animal test groups and drug dosages of different doses of compound a ointment

[0121] Table 2 Animal test groups and drug dosages for medium-dose compound a ointment

[0122] Example 3

[0123] The effective ingredients of the traditional Chinese medicine composition are prepared according to the following steps, which include the following steps:

[0124] Step S1: using a mechanical steel grinder to grind Indigo Naturalis, Lithospermum Officinale and Sophora flavescens into fine powder respectively, and passing through a 100-mesh sieve to obtain a fine powder mixture for later use;

[0125] Step S2: Weigh the indigo naturalis powder, lithospermum officinale powder and sophora flavescens powder prepared in step S1 according to the proportions and stir evenly;

[0126] Step S3: adding anhydrous ethanol at a liquid-to-solid ratio of 15 mL / g and refluxing and extracting at 80° C. for 2 h, repeating the extraction three times, combining the supernatants, recovering the ethanol, concentrating, and drying under reduced pressure to obtain an extract.

[0127] Example 3 The Chinese herbal ingredients can be mixed with a matrix carrier (such as beeswax) to form an emulsion, gel, ointment, cream, patch, liniment, aerosol, spray, lotion, serum, paste, foam or drops in the form of single or multiple doses.

[0128] The extract in Example 3 and camellia oil / beeswax (25:4, g / g) were prepared according to a mass ratio of 0.24 g crude drug / g ointment to obtain compound bj ointment. The proportions of each Chinese medicine raw material are detailed in Table 4.

[0129] Test Example 3

[0130] The compound bj ointment prepared in Example 3 was used for testing.

[0131] Test Example 3 Experiment 1: Preliminary determination of an effective dosage. This experiment was based on the effective therapeutic concentration in Compound A Ointment to obtain Compound B Ointment, that is, the mass ratio of Indigo Naturalis, Lithospermum Officinale, and Sophora Flavoring was 5:2:2, and the active ingredients were extracted to obtain an extract. Compound B Ointment was prepared according to the requirements of Example 3.

[0132] Forty BALB / c male mice, 6-8 weeks of age and standard body weight, were randomly divided into six groups, including a normal control group, a model group, a lowest dose group of compound b ointment (0.06 g crude drug / g ointment), a low dose group (0.12 g crude drug / g ointment), a medium dose group (0.24 g crude drug / g ointment), and a high dose group (0.48 g crude drug / g ointment). The details of the experimental animal groups and the drug dosage are shown in Table 3. The day before modeling, the back of the mice was shaved with a shaver and the hair was completely removed using a depilatory cream. The area was 2 × 5 cm. 2The normal control group had petroleum jelly applied to their backs, while the other groups were uniformly treated with imiquimod cream to create a psoriasis model. Each mouse received 62.5 mg / day for 10 consecutive days. Starting on the sixth day of modeling, mice were given imiquimod cream in the morning and 100 mg of Compound B ointment at varying concentrations in the afternoon. The normal control group received ointment base. Before modeling and treatment, the skin lesions of the mice were photographed and PASI scores were calculated.

[0133] Test Example 3 Experiment 2: Based on the screening results of the efficacy dose of Test Example 3 Experiment 1, 0.24g crude drug / g ointment was selected as the dosing concentration of this orthogonal experiment, and an orthogonal experiment of the optimal ratio of the three medicinal materials was conducted, that is, the compound bj ointment was used for efficacy treatment.

[0134] 85 BALB / c male mice, 6-8 weeks old and of standard weight, were randomly divided into 11 groups, including a normal control group, a model group, and a compound bj ointment group (all containing 0.24 g crude drug / g ointment). The day before modeling, the back of the mice was shaved with a shaver and the hair was completely removed with a depilatory cream, covering an area of ​​2 × 5 cm. 2 The normal control group had petroleum jelly applied to their backs, while the other groups were uniformly applied with imiquimod cream to create a psoriasis model. Each mouse received 62.5 mg / day for 10 consecutive days. Starting on the sixth day of modeling, imiquimod cream was administered in the morning, followed by a 100 mg application of the test ointment in the afternoon. The normal control group received the ointment base. The animal groupings and drug dosages for the orthogonal experiment are shown in Table 4. During modeling and treatment, the skin lesions of the mice were photographed before drug administration and PASI scores were calculated.

[0135] Test Example 3 Experiment 3: Based on the orthogonal test results of Test Example 3 Experiment 2, the optimal ratio of Indigo Naturalis: Lithospermum Officinale: Sophora flavescens was 5:1:3, and the active ingredients were extracted to obtain an extract. Compound K ointment was prepared according to the requirements of Example 3.

[0136] Forty BALB / c male mice, 6-8 weeks old and of standard weight, were randomly divided into five groups, including a normal control group, a model group, a low-dose group of compound k ointment (0.12 g crude drug / g ointment), a medium-dose group (0.24 g crude drug / g ointment), and a high-dose group (0.48 g crude drug / g ointment). The day before modeling, the back of the mice was shaved with a shaver and the hair was completely removed with a depilatory cream. The area was 2 × 5 cm. 2The normal control group had petroleum jelly applied to their backs, while the other groups were uniformly applied with imiquimod cream to create a psoriasis model, 62.5 mg / day per mouse, for 10 consecutive days. Starting on the sixth day of modeling, imiquimod cream was administered in the morning, followed by 100 mg of Compound K ointment at varying concentrations in the afternoon. The normal control group was given the ointment base. The grouping and drug dosage for the efficacy study of Compound K ointment are shown in Table 5. During modeling and treatment, the skin lesions of the mice were photographed before drug administration and PASI scores were calculated.

[0137] PASI score indicators:

[0138] 0 (none): No erythema or scales are visible on the skin surface, and the skin lesions are equivalent to normal healthy skin.

[0139] 1 (low grade): The lesions are partially covered with scales, mainly small pieces of dandruff. The lesions are slightly more advanced than normal skin and are light red.

[0140] 2 (Moderate): Most of the skin is partially or completely covered with scales with moderate ridges and red, rounded or beveled edges.

[0141] 3 (severe): Almost the entire surface of the lesion is covered with thick layered scales. The lesion is thick, dark red, and has obvious ridges.

[0142] 4 (extremely severe): The entire surface of the lesion is covered with thick layered scales. The lesion is very thick, very red in color, and has very obvious ridges.

[0143] Total score: the sum of the three scores of skin erythema, thickness and scaling.

[0144] Experimental results:

[0145] (1) As shown in Figure 4, compared with the model group, the lowest dose of compound b ointment could significantly reduce the erythema score of the skin lesions of the model mice starting from the fourth day of treatment, and the low, medium and high doses of compound b ointment could significantly reduce the erythema score of the model mice starting from the fifth day of treatment; the medium and high doses of compound b ointment could significantly reduce the thickness of the lesion skin of the model mice starting from the fifth day of treatment; the lowest dose of compound b ointment could improve the PASI total score of the mouse model starting from the fourth day of treatment, and the medium and high doses of compound b ointment could improve the PASI total score of the mouse model starting from the fifth day of treatment.

[0146] Based on the above results, both the medium-dose and high-dose groups of compound B ointment can effectively improve the symptoms of psoriasis lesions, so the medium dose (0.24g crude drug / g ointment) was selected for further efficacy verification.

[0147] (2) As shown in Figure 5, compared with the model group, compound e ointment can significantly reduce the erythema score of the skin lesions of the model mice starting from the fourth day of treatment; compound e and g ointments can significantly reduce the thickness of the lesion skin of the model mice starting from the third day of treatment, compound d ointment can significantly reduce the thickness of the lesion skin of the model mice starting from the fifth day of treatment, and compound b, c, d, e, f, g and i ointments can all significantly reduce the thickness of the lesion skin of the model mice on the sixth day of treatment; compound e ointment can significantly reduce the thickness of the lesion skin of the model mice starting from the second day of treatment. Compound d and g ointments could significantly reduce the scales at the skin lesions of the 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 lesions of the model mice on the sixth day of treatment; compound e ointment could improve the PASI total score of the mouse model starting from the third day of treatment, compound d ointment could improve the PASI total score of the mouse model starting from the fourth day of treatment, and compound g and i ointments could improve the PASI total score of the mouse model on the sixth day of treatment.

[0148] (3) As shown in Figure 6, compared with the model group, low-dose and medium-dose compound k ointment can significantly reduce the thickness of the lesion skin of the model mice starting from the second day of treatment, and high-dose compound k ointment can significantly reduce the thickness of the lesion skin of the model mice starting from the fourth day of treatment; low-dose compound k ointment can significantly and effectively reduce the scales in the lesion area of ​​the model mice starting from the fourth day of treatment; low-dose compound k ointment can improve the PASI total score of the mouse model starting from the third day of treatment, medium-dose compound k ointment can improve the PASI total score of the mouse model starting from the fourth day of treatment, and high-dose compound k ointment can improve the PASI total score of the mouse model starting from the fifth day of treatment; the above results show that the three doses of compound k ointment can improve the symptoms of psoriasis skin lesions, and the low dose (0.12g crude drug / g ointment) has a better therapeutic effect.

[0149] Table 3 Animal test groups and drug dosage of compound b ointment (Indigo naturalis: Lithospermum officinale: Sophora flavescens = 5:2:2)

[0150] Table 4 Animal grouping and drug dosage of orthogonal test (crude drug dosage is 0.24g / g ointment)

[0151] Table 5 Animal grouping of compound K ointment (Indigo: Lithospermum officinale: Sophora flavescens = 5:1:3)

[0152] Example 4

[0153] The active monomer component raw materials of Example 4 include: oxymatrine 1.17 mg / g ointment, shikonin 0.033 mg / g ointment, indigo 0.59 mg / g ointment, and indirubin 0.026 mg / g ointment.

[0154] The active 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, serum, paste, foam or drops in the form of single or multiple doses.

[0155] The monomer compound in Example 4 was prepared with camellia oil / beeswax (25:4, g / g) in a mass ratio to obtain an ointment.

[0156] Test Example 4

[0157] (1) Based on the three medicinal materials in compound a, the maximum extraction efficiency of each medicinal material was taken as the basis. The maximum extraction content of the effective active ingredient was taken in the experiment of test example 4, and the corresponding monomer compound ointment was prepared according to the requirements of example 3.

[0158] Forty BALB / c male mice, 6-8 weeks old and of standard weight, were randomly divided into six 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). The day before modeling, the backs of the mice were shaved with a shaver and a depilatory cream was used to completely remove the hair in an area of ​​2 × 5 cm. 2 The normal control group had petroleum jelly applied to their backs, while the other groups were uniformly applied with imiquimod cream to create a psoriasis model. Each mouse received 62.5 mg / day for 10 consecutive days. Starting on the sixth day of modeling, mice were given imiquimod cream in the morning for modeling and 100 mg of the test ointment was applied in the afternoon. The normal control group received the ointment base. The grouping and drug dosage for the efficacy trials of different monomer compound ointments are shown in Table 6. During modeling and treatment, the mouse skin lesions were photographed before drug administration and PASI scores were calculated.

[0159] (2) Based on the efficacy results in experiment (1), the oxymatrine / indigo paired combination ointment was used for further efficacy verification.

[0160] Forty BALB / c male mice, 6-8 weeks old and of standard weight, were randomly divided into six groups, including a normal control group, a model group, a compound a ointment group (0.24 g 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). The day before modeling, the backs of the mice were shaved with a shaver and the hair was completely removed using a depilatory cream, covering an area of ​​2 × 5 cm. 2The normal control group had petroleum jelly applied to their backs, while the other groups were uniformly applied with imiquimod cream to create a psoriasis model. Each mouse received 62.5 mg / day for 10 consecutive days. Starting on the sixth day of modeling, mice were given imiquimod cream in the morning for modeling and 100 mg of the test ointment was applied in the afternoon. The normal control group received the ointment base. The grouping and drug dosage for the efficacy test of the monomer composition ointment are shown in Table 7. During modeling and treatment, the mouse skin lesions were photographed before drug administration and PASI scores were calculated.

[0161] PASI score indicators:

[0162] 0 (none): No erythema or scales are visible on the skin surface, and the skin lesions are equivalent to normal healthy skin.

[0163] 1 (low grade): The lesions are partially covered with scales, mainly small pieces of dandruff. The lesions are slightly more advanced than normal skin and are light red.

[0164] 2 (Moderate): Most of the skin is partially or completely covered with scales with moderate ridges and red, rounded or beveled edges.

[0165] 3 (severe): Almost the entire surface of the lesion is covered with thick layered scales. The lesion is thick, dark red, and has obvious ridges.

[0166] 4 (extremely severe): The entire surface of the lesion is covered with thick layered scales. The lesion is very thick, very red in color, and has very obvious ridges.

[0167] Total score: the sum of the three scores of skin erythema, thickness and scaling.

[0168] Experimental results:

[0169] (1) As shown in Figure 7, compared with the model group, the indigo ointment group could significantly reduce the erythema score of the skin lesions of the model mice on the fifth day of treatment; the shikonin ointment group could significantly reduce the thickness of the lesion skin of the model mice starting from the second day of treatment, and the oxymatrine ointment group and the indirubin ointment group could significantly reduce the thickness of the lesion skin of the model mice starting from the third day of treatment; the indigo ointment group could significantly reduce the scales of the skin lesions of the model mice on the fifth day of treatment; the shikonin ointment group and the indigo ointment group could improve the PASI total score of the mouse model starting from the third day of treatment.

[0170] (2) As shown in FIG8 , compared with the model group, the compound a ointment group and the oxymatrine / indigo ointment group could significantly reduce the erythema score of the skin lesions of the model mice starting from the third day of treatment, and the indigo ointment group could significantly reduce the erythema score of the skin lesions of the model mice starting from the sixth day of treatment; the compound a ointment group, the oxymatrine ointment group and the oxymatrine / indigo ointment group could significantly reduce the thickness of the lesion skin of the model mice starting from the fourth day of treatment; the oxymatrine / indigo ointment group could significantly reduce the scales of the skin lesions of the model mice starting from the fourth day of treatment; the oxymatrine / indigo ointment group could improve the PASI total score of the mouse model starting from the third day of treatment, and the compound a ointment group and the oxymatrine ointment group could improve the PASI total score of the mouse model starting from the fourth day of treatment.

[0171] Table 6 Grouping and drug dosage of the monomer composition ointment in the treatment of psoriasis mouse model

[0172] Table 7 Grouping and drug dosage of the efficacy test of the monomer composition ointment

[0173] 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 lesions of the psoriasis mouse model.

[0174] In addition, the results of the efficacy experiments of the three herbs in different proportions showed that, as shown in Table 8, the active ingredient indigo was given in the tested ointment at 0.0023 to 0.0182 mg / cm 2 , indirubin 0.0005~0.0662mg / cm 2 , shikonin 0.00004~0.0038mg / cm 2 and oxymatrine 0.0016~0.1138mg / cm 2 Both can effectively reduce the erythema score of the psoriasis mouse model; the active ingredient indigo was given in the tested ointment at a dose of 0.0009-0.0178 mg / cm 2 , indirubin 0.0005~0.0662mg / cm 2 , shikonin 0.00001~0.0117mg / cm 2 and oxymatrine 0.0003~0.1138mg / cm 2 Both can effectively reduce the skin thickness score of the psoriasis mouse model; the active ingredient indigo was given in the tested ointment at a dose of 0.001-0.0178 mg / cm 2 , indirubin 0.0005~0.016mg / cm 2 , shikonin 0.00001~0.00411mg / cm 2 and oxymatrine 0.0003~0.1084mg / cm2 Both can effectively reduce the scale score of the psoriasis mouse model; the active ingredient indigo was given in the tested ointment at a dose of 0.0009-0.0182 mg / cm 2 , indirubin 0.0005~0.0662mg / cm 2 , shikonin 0.00001~0.0117mg / cm 2 and oxymatrine 0.0003~0.1138mg / cm 2 Both can effectively reduce the PASI total score of the psoriasis mouse model.

[0175] Table 8 Dosage of the active ingredients in compound ak, monomer and monomer pair ointment

[0176] The present invention is based on the theory of traditional Chinese medicine, adopts the theory of syndrome differentiation and treatment, and formulates the prescription according to the pathogenesis of skin diseases. The various components can coordinate and promote each other. The above experimental results show that the Chinese medicine compound preparation provided by the present invention has a good synergistic effect, and no adverse reactions were observed during the experiment, with high safety.

[0177] The present invention is directed to determining the content of the effective ingredients of the traditional Chinese medicine composition for treating psoriasis. The instruments, main compounds, and reagents used in the specific determination are as follows:

[0178] 1. Instruments, main compounds and reagents.

[0179] 1.1 Instruments:

[0180] Agilent 6470B triple quadrupole mass spectrometer LC / TQ; ultrasonic cleaner (Soner 220H, R℃KER); SECURA 125-1S electronic analytical balance (sartorius, d = 0.01 mg); water purifier (Milli-pore, model: IQ-7015); high-speed centrifuge (Eppendorf, model: 5425R).

[0181] 1.2 Main compounds and reagents:

[0182] 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%), and oxymatrine (CAS: 16837-52-8, batch number MUST-21080910, purity>98%) were purchased from Chengdu Mansite Biological Co., Ltd.

[0183] Acetonitrile was of chromatographic grade (Honeywell), formic acid was of chromatographic grade (VWR), N,N-dimethylformamide was of analytical grade (DUKSAN), ammonium acetate was of bioanalytical grade (Sigma-Aldrich), concentrated ammonia was of ACS grade (Honeywell), methanol was of chromatographic grade (RCI Labscan), and ultrapure water was homemade.

[0184] 2. Measurement method.

[0185] 2.1 Preparation of sample test solution:

[0186] Accurately weigh appropriate amounts of compound ak test samples, dissolve them in N,N-dimethylformamide, dilute with methanol, and shake well to obtain test sample solutions with different concentration gradients.

[0187] 2.2 Preparation of reference solution:

[0188] Accurately weigh appropriate amounts of indigo, indirubin, shikonin, and oxymatrine reference substances, dissolve them in N,N-dimethylformamide, dilute with methanol, and shake well to obtain indigo concentrations of 2.207 μg / ml, 1.104 μg / ml, 0.5518 μg / ml, and 0.2759 μg / ml, respectively; indirubin concentrations of 4.883 μg / ml, 2.441 μg / ml, 1.2207 μg / ml, and 0. .6104μg / ml, the shikonin concentrations were 2.000μg / ml, 0.400μg / ml, 0.080μg / ml, 0.016μg / ml, 0.0328μg / ml, 0.0064μg / ml, and the oxymatrine concentrations were 2.2773μg / ml, 1.3867μg / ml, 0.6934μg / ml, 0.3467μg / ml.

[0189] 2.3 Determination method: Use ultra performance liquid chromatography-triple quadrupole tandem mass spectrometry (UPLC-QqQ-MS / MS) to accurately aspirate the reference solution and the test solution, inject them into the analytical instrument, and determine the result.

[0190] Determination method of oxymatrine content:

[0191] Chromatographic conditions: Separation was performed using an Agilent ZORBAX Eclipse Plus C18 column (2.1 × 5 mm, 1.8 μm) as a precolumn and an Agilent ZORBAX Eclipse Plus C18 column (2.1 × 100 mm, 1.8 μm). Flow rate: 0.4 mL / min, column temperature: 40°C, injection volume: 1 μL. Gradient elution: Mobile phase A: 0.01 mol / L ammonium acetate-water solution (pH adjusted to 8.0 with ammonia), mobile phase B: acetonitrile. Flow rate: 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.

[0192] Mass spectrometry parameter conditions:

[0193] Detection was performed in ESI mode, and the scanning mode was multiple reaction monitoring (MRM). The following parameters were used:

[0194] Drying gas temperature: 350°C, drying gas flow rate: 10 L / min, nebulizing gas pressure: 45 psi, nitrogen as nebulization 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 component (oxymatrine): 265.2 / 247.1; collision energy (CE): 29 V.

[0195] Determination method of indigo, indirubin and shikonin:

[0196] Ultra-performance liquid chromatography-triple quadrupole tandem mass spectrometry (UPLC-QqQ-MS / MS) was used for separation using an Agilent ZORBAX Eclipse Plus C18 column (2.1 × 5 mm, 1.8 μm) as a precolumn and an Agilent ZORBAX Eclipse Plus C18 column (2.1 × 100 mm, 1.8 μm) as a column. The flow rate was 0.4 mL / min, the column temperature was 40°C, and the injection volume was 1 μL. Gradient elution conditions were: mobile phase A consisted of 0.1% formic acid in water, and mobile phase B consisted of 0.1% formic acid in acetonitrile. The gradient elution time was 0–10 min, 5% to 80% B; 10.0–10.1 min, 80% to 100% B; 10.1–13 min, 100% B; and 13–14 min, 100% to 5% B.

[0197] Mass spectrometry parameter conditions:

[0198] Detection was performed in ESI mode, and the scanning mode was multiple reaction monitoring (MRM). The following parameters were used:

[0199] Drying gas temperature: 350°C, drying gas flow rate: 10 L / min, nebulizing gas pressure: 45 psi, nitrogen as the nebulization 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.

[0200] The above-mentioned step S2.3 determination method includes the determination of the linear relationship: accurately aspirate the reference solution, dilute it step by step, and obtain a series of concentration solutions with different dilution multiples. The solutions are measured separately under the test conditions, and the chromatographic peak areas of the four chemical components are recorded. The standard curve is drawn with the mass concentration of the reference as the horizontal axis (X) and the peak area as the vertical axis (Y). A linear regression is performed to obtain the standard curve equation. The linear equations, correlation coefficients and linear ranges of the four chemical components in the present invention are shown in Table 9.

[0201] 3. Experimental results:

[0202] The chromatogram of the four chemical components in the reference solution shown in Figure 9 and the content detection results shown in Table 10 show that the four chemical components measured in the present invention can be effectively separated under the gradient elution conditions of this system, and the analysis cycle of the method is short and the separation efficiency is high. Mass spectrometry has high sensitivity and strong selectivity. It can accurately determine the content of the components while accurately giving its mass number information, thereby achieving the effect of identifying the compound. The present invention performs quantitative analysis on the four different types of compounds in the compound, and the operation is fast, the repeatability is good, and the results are accurate and reliable, which can provide a basis for the comprehensive quality control of the present invention. Figure 10 is a chemical structural formula diagram of the four components to be measured in the test solution of the present invention.

[0203] Table 9 Linear equations, correlation coefficients and linear ranges of the four chemical components in the present invention

[0204] Table 10 Extract content determination results

[0205] The preferred embodiments of the present invention have been described in detail above. However, the present invention is not limited to the specific details of the above embodiments. Within the scope of the technical concept of the present invention, various simple variations of the technical solution of the present invention can be made. These simple variations all fall within the scope of protection of the present invention.

[0206] It should also be noted that the various specific technical features described in the above specific embodiments can be combined in any manner without contradiction. To avoid unnecessary repetition, the present invention will not further describe various possible combinations.

[0207] In addition, the various embodiments of the present invention may be arbitrarily combined, and as long as they do not violate the concept of the present invention, they should also be regarded as the contents 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 in parts by mass: 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 invention is prepared from the following Chinese medicinal raw materials by weight: 16 to 56 parts of indigo naturalis, 11 to 50 parts of lithospermum officinale and 16 to 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 to 25 mL / g, and reflux extraction is performed at a temperature of 70 to 100° C. for 1 to 3 hours. The extraction is repeated 1 to 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